Thông tư 08/2009/TT-BYT Danh mục thuốc không kê đơn

CIRCULAR

LIST OF OVER-THE-COUNTER (OTC) DRUGS

Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Pharmacy Law No. No. 34/2005/QH11 dated June 14, 2005;

To ensure the safety for the drug users and create favorable conditions for the patients to buy drug to treat minor illnesses and common symptoms by themselves. The Ministry of Health issues and guides the implementation the "List of OTC drugs" as follows:

Article 1. Issuing together with this Circular the "List of OTC drugs", including:

1. List of pharmaceutical drugs;

2. List of drugs originated from medicinal herbs.

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1. OTC drugs are the drug dispensed, sold and used without prescription;

2. Prescription drugs are the drugs if not used in accordance with the prescriber’s indication, they may be dangerous to life or health; it is required to follow the prescription when dispensing, retailing and using these drugs for the outpatients;

Article 3. Principle to develop the “List of OTC drugs”

1. The list of OTC drugs is developed on the basis of specific criteria of pharmacological properties and safety of the drug.

2. The list of OTC drugs is developed in accordance with actual use and supply of drug of Vietnam and with the reference of classification of OTC drugs (Over The Counter) from a number of countries such as Australia, the USA, European countries, Philippines, Singapore and China;

3. The list of OTC is modified and supplemented annually. In case of necessity, in order to ensure the user’s safety, a number of types of drug may be removed from the list of OTC drugs if they have serious adverse effect detected;

Article 4. Criteria for selection of OTC drugs

Drugs simultaneously satisfy the following criteria shall be selected in the list of OTC drugs:

1. The drug has low toxicity, does not generate decomposition products with toxicity has no serious adverse effects (adverse effects are the consequences of death, danger to life and hospitalization is required for treatment or prolonged treatment, causing permanent or severe disability, birth defect, congenital malformation and equivalent consequences, ...) that have been known and / or warned work of these effects.

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3. Drugs are indicated for the treatment of common diseases and patients can treat themselves, unnecessary examination, consultation and monitoring from the physician.

4. Simple route and form of administration (mainly the oral and administration) with the content and concentration suitable for self-treatment.

5. Drugs have little interaction with other drugs and common food and beverage;

6. Drugs do not cause the drug dependence.

Article 5. Application of “List of OTC drug”

1. The list of OTC drugs is the basis for classification of OTC drugs and prescription drugs. The OTC drugs are permitted for dispensation, sale and use without prescription;

2. The list of OTC drugs is the legal grounds for the formulation and promulgation of regulations and guidelines for the OTC drugs in registration, production, import, export, circulation, distribution of drug, information of drug advertisements and scope of activities of drug retail establishments.

3. For drugs indicated as contraceptive pills that are classified as OTC drugs in this List, the medical officers shall guide the use of drug prior to dispensation or sale to consumers.

4. Other scopes of application of List of OTC drugs shall be guided in the relevant documents;

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1. For drug retail establishments:

From the effective date of this Circular, the drug retail establishments are permitted to retail drugs without prescription for the drugs specified in the List of OTC drugs;

2. For drug production and trading establishments:

a) For dossiers to register drug circulation in Vietnam and dossier to import drug without registration number that have been submitted in the Drug Administration of Vietnam before the effective date of this Circular, the establishments must classify, modify and supplement documents related to the classification of drug under the provisions of this Circular before considering the issuance of registration number or import license;

b) For the drugs that already have their registration number or permitted for import before the effective date of this Circular:

- The drugs that are produced and imported within 12 months from the effective date of this Circular and put into circulation in the market shall be permitted for circulation to the their expiration;

- After 12 months from the effective date of this Circular, the establishments that must classify, update and supplement information on drug labels and drug facts related to the classification of drug under the provisions of this Circular shall be permitted for putting their drugs into circulation on the market;

Article 7. Implementation provision

1. This Circular takes effect 45 days after its signing date;

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3. Any difficulty arising during the implementation of this Circular should be promptly reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and settlement./.

FOR THE MINISTER
DEPUTY MINISTER




Cao Minh Quang

LIST OF OTC DRUGS

(Issued together with Circular No. 08/2009/TT-BYT dated July 01, 2009)

1. LIST OF PHARMACEUTICAL DRUGS:

No.

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Route of administration, dosage form, limit of content and concentration

Note

1

Acetylcysteine

Oral administration: various forms

2

Acetylleucin

Oral administration: various forms

...

...

...

3

Acetylsalicylic acid (Aspirin) of pure form or mixed with vitamin C and / or citric acid and / or sodium bicarbonate and / or sodium salicylate

Oral administration: various forms

Topical administration: various forms

4

Alginic acid (sodium alginate) of pure form or mixed with compounds of aluminum and magnesium

Oral administration: various forms

...

...

...

Amino acid of pure or mixed form (including form mixed with Vitamins)

Oral administration: various forms

Indication: supplemental amino acid and vitamins for body

6

Acid Aminobenzoic (Acid para aminobenzoic)\ Aminobenzoic acid (para aminobenzoic acid)

Oral administration: various forms

7

Pure or mixed Benzoic acid

...

...

...

Oral administration: lozenge

8

Pure or mixed boric acid

Topical administration

Eye drops and ointment

9

Citric acid mixed with sodium, potassium

...

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10

Cromoglicic acid and forms of Natrium cromoglicat

Eye drops and ointment and nose drops with concentration limit by Cromoglicic acid ≤ 2%

11

Acid Dimecrotic Dimecrotic acid

Oral administration: various forms

...

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...

Folic Acid of pure form or mixed with iron and / or vitamins of group B, minerals and Sorbitol

Oral administration: various forms

Indications: prevention of anemia, nutritional supplements

13

Glycyrrhizinic acid (Glycyrrhizinat) mixed with a number of other active susbtances such as Chlorpheniramine maleate, dl-methylephedrin, Caffeine ...

Oral administration: various forms, including forms of lozenge

Topical administration

14

...

...

...

Oral administration: various forms

15

Salicylic Acid of pure or mixed form in topical finished products (mixed with Lactic acid, precipitated sulfur ...)

Topical administration

16

Acyclovir Aciclovir

Dermal drug with concentration of Acyclovir ≤ 5%

...

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17

Albendazole

Oral administration: various forms

Indication: worm treatment

18

Dichlorobenzyl alcohol of mixed form in lozenge ingredients

Oral administration: lozenge

19

...

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...

Topical administration

20

Alimemazine tartrate (Trimeprazine tartrate)

Oral administration: various forms

21

Allantoin mixed in topical ingredients, Suppository (Cao Cepae fluid; Heparin...) 

Topical administration

...

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22

Allatoin mixed with Vitamins and/or Chondroitin 

Eye drops and ointment

23

Almagate

Oral administration: various forms

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Ambroxol pure or mixed form in topical finished products of cough, antipyretic or analgesic drug

Oral administration: various forms with limit of active ingredients as follows:

- Divided dose: Ambroxol chlorhydrate ≤ 30 mg/unit

- Undivided dose: Ambroxol chlorhydrate ≤ 0.8% 

25

Amyllase of pure form or mixed with Protease and / or lipase and / or Cellulase 

Oral administration: various forms

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Amylmetacresol of mixed form with finished products of lozenge (as essential oil, Bacitracin...)

Oral administration: lozenge

27

Argyron

Eye drops and ointment

Topical administration

28

...

...

...

Oral administration: various forms

29

Aspartate

Oral administration: various forms

30

Attapulgit

Oral administration: various forms

...

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31

Azelastine

Eye drops and ointment and nose drops

32

Silver Sulphadiazine

Topical administration

33

...

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...

Oral administration: various forms

34

Freeze-dried bacillus subtilis

Oral administration: various forms

35

Bacitracin mixed with a number of active ingredients in finished products of lozenge (mixed with Neomycin sulfate; Amylocain; Tixocortol ...)

Oral administration: lozenge

...

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...

.

36

Beclomethasone dipropionate

Nose drug: form of spray with limited maximum dosage for 01 day ≤ 400mcg (based on active ingredients without salt)

37

Benzalkonium mixed in topical finished products (with Choline; salicylic acid; Nystatin; Diiodohydroxyquin ...), in finished products of lozenge

Topical administration

Oral: lozenge

...

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38

Benzocaine in mixed form

Topical administration: various forms with limited Benzocain ≤ 10%;

Suppository

Oral administration: lozenge

39

Benzoyl peroxide of pure form or mixed with iodine and / or sulfur

...

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40

Benzydamin HCl of pure or mixed form

Topical administration: oral mucosa cream, mouthwash and throat spray

Oral administration: lozenge

41

Benzydamin salicylates of pure or mixed form

Topical administration

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42

Benzyl benzoate mixed in topical finished products (with essential oil, Isopropyl alcohol ...) 

Topical administration: various forms

Dermal patch

43

Berberin

Oral administration: various forms

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Biclotymol of pure form or mixed with Enoxolon and/or Phenylephrine HCl and / or Chlorpheniramine maleate and / or essential oil

Topical administration Nose drug

Oral administration: lozenge

45

Bifonazol of pure form or mixed with Urea

Topical administration

46

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Oral administration: various forms with divided dosage with content ≤ 10mg/unit

47

Boldin

Oral administration: various forms

48

Bromelain of pure form or mixed with Trypsin

Oral administration: various forms

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49

Bromhexine HCl of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as with Dextromethorphan HBr; Diphenhydramine; Guaiphenesin ...)

Oral administration: various forms with limited Bromhexin HCl as follows:

- Divided dosage ≤ 8mg/unit;

- Undivided dosage ≤ 0,8%

Suppository

50

Brompheniramin maleate of pure or mixed form in finished products of cough, antipyretic and analgesic drug

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51

Budesonid

Budesonid

Bufexamac of pure or mixed form in topical finished products, suppository (as with titanium dioxide, bismuth, Subgallat, Lidocaine ...)

Nose drug: form of spray, inhaler and powder for inhalation with a limited maximum dosage for 01 day ≤ 400mcg and packed form≤ 200 dosages

Topical administration

Suppository

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Butoconazol

Topical administration 

53

Calcium compounds (except for calcitriol) of single form or mixed with Vitamin D and / or Vitamins and / or Ipriflavon

Oral administration: various forms

Indication: Supplemental calcium for body

54

The compounds of aluminum, magnesium, calcium of pure or mixed form

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Indication: neutralizing gastric acid, gastric and duodenal ulcer treatment,.

55

Iron compounds

Oral administration: various forms

Indication: supplemental iron for body

56

Enzymes of pure form or mixed with vitamins

Oral administration: various forms

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57

Bismuth salts

Oral administration: various forms

58

Magnesium salts

Oral administration: various forms

Indications: providing supplemental magnesium for body, neutralizing laxative gastric acid;

59

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...

Oral administration: various forms

Indications: providing supplemental minerals for the body, including mixed forms with vitamins.

60

The essential oil (Menthol, Pinen, Camphor; Cineol, Fenchone, Borneol, anethole, Eucaliptol ...)

Oral administration: various forms

Dermal drug, mouthwash, throat spray and oral mucosa cream

61

Calamine of pure or mixed form in topical finished products

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Topical administration

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage: ≤120mg/ unit;

- Unvided dosage: ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

62

Carbocystein

Oral administration: various forms

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Carbomer

Topical administration

Eye drops and ointment

64

Catalase of pure or mixed form in topical finished products (with Neomycin)

Topical administration

65

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Oral administration: various forms

66

Cetrimide mixed with a number of active ingredients in topical finished products (Lidocaine, Zinc, Calamine, Aminacrine, essential oil ...)

Topical administration

67

Cetrimonium mixed in topical finished products and lozenge (mixed with Lidocaine; Tyrothricin, essential oil ...)

Topical administration

...

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68

Chitosan (Polyglusam)

Topical administration

69

Choline of pure form or mixed with amino acids and vitamins in oral finished products; mixed with salicylic acid, benzalkonium ...in topical finished products

Oral administration: various forms

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70

Chondroitin of pure form or mixed with Glucosamine and / or fish oil and / or vitamins and / or amino acid

Oral administration: various forms

71

Chondroitin mixed with Vitamins

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72

Chondroitin mixed in topical finished products

73

Ciclopirox olamine

74

Cimetidin

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75

Cinarizin

Oral administration: various forms

76

Cinchocaine mixed in topical finished products, suppository (as with hydrocortisone, neomycin, Esculin ...)

Topical administration

Suppository

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77

Citrulline

Oral administration: various forms

78

Clobetason butyrate

79

Clorhexidin

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80

Clorophyll

Oral administration: various forms

81

Clorpheniramine maleate of pure or mixed form in finished products of cough, antipyretic and analgesic drug (mixed with with Phenylephrine HCl, paracetamol, Dextromethorphan HBr ...)

Oral administration: various forms.

Pure form of divided dosage: Clorpheniramine maleate ≤ 4mg/

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Clorpheniramine maleate mixed and/or vitamins

Eye drops and ointment

83

Clotrimazol

Topical administration: various forms with limited concentration ≤ 3%

Vaginal tablet

84

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Oral administration: various forms

85

Crotamiton

86

Copper sulfate

87

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Dexbrompheniramin maleat of pure or mixed form in in finished products of cough, antipyretic and analgesic drug

Topical administration

Vaginal tablet

Oral: lozenge

Oral administration: various forms

88

Dexbrompheniramin maleat of pure or mixed form in in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms

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89

Dexibuprofen

Oral administration: various forms

90

Dexpanthenol

Eye drops and ointment

Topical administration

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Dextromethorphan HBr of pure or mixed form in in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms with the following limit (by base form):

-Divided form: Dextromethophan ≤ 15mg;

- Undivided form: Dextromethophan ≤ 0.6%;

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

92

Diclofenac of pure form or mixed with Methyl salicylate, essential oil…

Topical administration

Eye drops and ointment (pure form)

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93

Dicyclomine

Oral administration: various forms

94

Diethylphtalat (DEP)

Topical administration

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Dimenhydrinate

Oral administration: various forms

96

Dimethicone (Dimethylpolysiloxan) of pure form or mixed with với Guaiazulene

Oral administration: various forms

97

Dimethicon mixed in topical finished products (with zinc, calamine; Cetrimid ...)

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98

Dimethindene

Oral administration: various forms

Topical administration

99

Inosine monophosphate dinatri

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100

Diosmectite (Dioctahedral smectite)

Oral administration: various forms

101

Diosmin mixed with Hesperidin and/or a number of medicinal glue containing Flavonoid

Oral administration: various forms

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Diphenhydramine hydrochloride or monocitrat

Oral administration: various forms with the following limit (by base form):

- Divided dosage ≤ 50mg/unit;

- Undivided dosage: ≤ 2.5%

103

Domperidon

Oral administration: various forms with the following limit:

- Divided dosage ≤ 10mg/ unit;

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104

Doxylamin mixed in finished products of cough, antipyretic and analgesic drug (as with Paracetamol;

Pseudoephedrin HCl;

Dextromethorphan HBr; Vitamins...)

Oral administration: various forms with limited Pseudoephedrin as follows (by base form):

- Divided dosage ≤ 120mg/ unit;

- Undivided dosage ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

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Econazole of pure form or mixed with Hydrocortison

Topical administration, limited concentration of Hydrocortison by base form≤ 0.05%

106

Enoxolone of pure or mixed form in topical finished products and lozenges

Topical administration: Dermal drug, oral mucosa cream, mouthwash

Oral administration: lozenge

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Ephedrin HCl

Eye and nose drug: lotion ≤ 1%

108

Eprazinon

Oral administration: various forms

109

Esdepallethrin mixed in topical finished products (with Piperonyl, Spregal, essential oil…)  

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110

Estradiol in pure form and mixed with Dydrogesteron 

Oral administration: drug with divided dosage

Indication: contraception

111

Ethanol of pure or mixed form

Topical use (antiseptic alcohol)

Oral administration: mixed form

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112

Ethinylestradiol in pure form and mixed with Cyproteron

113

Ethylestradiol in pure form and mixed with Desogestrel

114

Ethylestradiol in pure form and mixed with Gestodene

115

Ethylestradiol in pure form and mixed with Levonorgestrel

116

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Topical administration

117

Famotidin

Oral administration: various forms

To be sold without prescription for 15 days of use

118

Fenticonazol

Topical administration

...

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119

Fexofenadin

Oral administration: various forms

120

Flurbiprofen

Lozenge

Topical administration

Eye drops and ointment

...

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121

Glucosamin of pure form or mixed with Chondroitin and/or with Vitamins

Oral administration: various forms

122

Glucose or Dextrose of pure form or mixed with sodium, potassium

Oral administration: various forms

Indication: supplemental sugar and electrolytes.

123

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Topical administration

Eye drops and ointment

124

Glycerol mixed with herbal extracts

Drug of rectal enema

125

Guaiphenesin of pure or mixed form in finished products of cough, antipyretic and analgesic drug (with Paracetamol; Pseudoephedrin HCl; Dextromethorphan HBr...) 

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- Divided dosage form ≤120mg/ unit;

- Undivided dosage form ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

126

Hexamidin of pure form or mixed (with Cetrimid, Lidocain, Clotrimazol, Catalase)

Topical administration

127

Hexetidin of pure form or mixed (with Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, essential oil...)

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128

Hydrocortison of pure form or mixed (with Miconazol, Econazol, Tioconazol, Neomycin)

Topical administration: various forms with concentration of Hydrocortison ≤ 0.5%

129

Hydrogen Peroxid of pure form or mixed with Sodium Lauryl Sulfate and / or essential oil ...

Topical administration

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Hydrotalcit

 Oral administration: various forms

131

Hydroxypropyl methylcellulose (HPMC)

Eye drops and ointment

132

Hypromellose of pure form or mixed with Dextran 70

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133

Ibuprofen

134

Ichthammol

135

Indomethacin

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136

Iodide mixed with Potassium iodide and / or benzoic acid and / or salicylic acid

Topical administration with concentration of iodine ≤ 5%

137

Isoconazol

138

Isopropyl Methylphenol

...

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139

Ketoconazol of pure form or mixed with Zinc Pirythion and / or hydrocortisone and / or Trolamin

Topical administration: various forms with concentration of Ketoconazol ≤ 2%

140

Ketoprofen

141

Zinc oxide, Zinc pyrithion, zinc gluconate, zinc undecylenat of pure or mixed form in topical finished products

...

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142

Zinc sulfate

Topical administration

Eye drops and ointment

143

Lactic acid bacillus of pure form or mixed with vitamins

Oral administration: various forms

...

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Lactitol

Oral administration: various forms

145

Lactobacllus acidophilus

Oral administration: various forms

146

Lactobacllus acidophilus of pure form or mixed with vitamins

...

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147

Lactoserum atomisate (Lactacyd)

Topical administration 

148

Lactulose

Oral administration: various forms

...

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Levocetirizin

Oral administration: various forms

150

Levonorgestrel of pure form or mixed with Ethylestradiol

Oral administration: various forms

Indication: contraception

151

Lindan (Benhexachlor, 666, Gamma-BHC) of pure form or mixed with Lidocain

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152

Loperamid

Oral administration: various forms with a limited content of divided dosage of Loperamid ≤ 2mg  

153

Loratadin of pure form or mixed with Pseudoephedrin HCl

Oral administration: various forms with limited content as follows (by base form):

- Divided dosage:

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...

Pseudoephedrin ≤ 120mg/unit

- Divided dosage:

Loratadin ≤ 0.1%

Pseudoephedrin ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

154

Loxoprofen

Oral administration: various forms

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Lysozym of pure form or mixed with Tocopherol, Nicotinate, Carbazochrom, Inositol Cetylpyridinium,...

Oral administration: various forms

Topical administration 

156

Macrogol

Oral administration: various forms

Drug of rectal enema

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Magaldrat of pure form or mixed with the active ingredients of Aluminum, Magnesium, alginic acid (or alginate salt).

Oral administration: various forms

158

Mangiferin

Topical administration 

159

Mebendazol 

...

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...

- Divided dosage form ≤ 500mg/unit

- Undivided dosage form ≤ 2%

160

Mebeverin

Oral administration: divided dosage form ≤ 200mg/unit

161

Fungal cellulase

...

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162

Menthol mixed with a number of active ingredients such as mixed essential oil, Methyl Salycilat.... 

Oral administration: various forms

Topical administration: various forms

163

Mequinol

Topical administration

...

...

...

164

Mequitazine

Oral administration: various forms

Topical administration

165

Mercurocrom

Topical administration with packaging specifications ≤ 30ml

To be sold with no more than 2 packaging units/time

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Methyl salicylate mixed in finished products of lozenge and topical administration (mixed with essential oil…)

Topical administration

Dermal patch

Oral administration: lozenge

167

Metronidazol

Topical administration

...

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...

Miconazol

Topical administration

Vaginal cream≤ 2%  

169

Miconazole mixed with Hydrocortison

Topical administration

Vaginal cream

Miconazol ≤2%; Hydrocortison ≤0.05%

...

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170

Minoxidil

Topical administration: various forms with concentration of ≤5%

171

Mometasone

Nose drug: ≤ 50 mcg/time of spray with packaging specification≤ 200 dosages/box;

 Topical administration

...

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...

Mupirocin

Topical administration

173

Myrtol of pure or mixed form in finished products of lozenge

Naphazolin of pure or mixed form in finished products of nose drug such as Diphenylhydramin and/or Procain

Oral administration: various forms

Nose drug with concentration of Naphazolin ≤ 0.05%

...

...

...

174

Naphazolin mixed in finished products of Eye drops and ointment (Pheniramin; Vitamin glycyrhizinat, Dexpanthenol...)

Eye drops and ointment: various forms with concentration of Naphazolin ≤ 0,1%

175

Naproxen

Oral administration: various forms with divided dosage of Naproxen ≤ 250mg/unit

...

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...

Sodium benzoate of pure or mixed form

Oral administration: various forms

177

Sodium bicarbonate of pure or mixed form

Oral administration: various forms

178

Sodium carbonate of pure or mixed form

...

...

...

179

Sodium carboxymethylcellulose (Na CMC)

Eye drops and ointment

180

Sodium chloride of pure form or mixed with potassium citrate, sodium citrate ...

Oral administration: various forms

Topical administration

...

...

...

181

Sodium Docusat

Oral administration: various forms

182

Sodium fluoride of mixed form

Topical administration:

Tooth cleaning and mouthwash

...

...

...

183

Natri Hyaluronat (Acid Hyaluronic)

Topical administration

184

Sodium Monofluorophosphat

Topical administration:

Tooth cleaning and mouthwash

...

...

...

Sodium salicylate of mixed form

Oral administration: mixed form in lozenges

Topical administration

186

Neomycin sulfate mixed in finished products of lozenge (Zinc, Bacitracin; Amylocain ...) and topical finished products

Nomahydrated sodium sulfide + Saccharomyces Cerevisiae

Topical administration

Oral administration: various forms

...

...

...

187

Noscarpine

Oral administration: various forms

188

Nystatin of pure or mixed form

Topical administration

...

...

...

Orlistat

Oral administration: various forms

190

Ossein hydroxy apatite

Oral administration: various forms

191

Oxeladin

...

...

...

182

Oxymemazin

Oral administration: various forms

193

Oxymetazoline

Nose drug with concentration ≤ 0,5%

...

...

...

Pancreatin of pure form or mixed with Simethicon and / or digestive enzymes and / or the vitamins of group B and / or Azintamid

Oral administration: various forms

.

195

Panthenol

Topical administration

Eye drops and ointment

196

...

...

...

Oral administration: various forms

Suppository

Mixed form specified in the List

197

Paracetamol mixed with Ibuprofen and/or Cafeine

Oral administration: various forms

198

...

...

...

Oral administration: various forms

199

Paracetamol mixed with Promethazin HCl

Oral administration: various forms with limited content and concentration (by base form) as follows:

- Divided dosage: Promethazin ≤12.5mg/unit;

- Undivided dosage: Promethazin ≤ 0.1%

Suppository

...

...

...

200

Paracetamol mixed with Codein

Oral administration: various forms with limited Codein (by base form) as follows:

- Divided dosage form≤ 30mg/unit;

- Undivided dosage ≤ 2.5%

Finished products containing Codein are sold without prescription with a maximum amount for 10 days of use.

201

Paracetamol mixed with Pseudoephedrine HCl and/or Vitamin C and/or one of the active ingredients:

...

...

...

Dextromethorphan HBr;

Phenylephrine HCl

Oral administration: various forms with the limit (by base form) as follows: 

- Divided base form: Pseudoephedrin ≤ 120mg/unit;

Dextromethophan ≤ 15mg

- Undivided base form: Pseudoephedrin ≤ 0.5%

Dextromethophan ≤ 0.6%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

202

...

...

...

Oral administration: various forms

203

Phenylephrin HCl

Eye drops and ointment and nose drop with concentration ≤ 1%

204

Phenylephrin HCl mixed in topical finished products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil...)

Topical administration

...

...

...

205

Phenylephrin HCl mixed in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms

Suppository

206

Phospholipid

Oral administration: various forms

...

...

...

Picloxydine

Eye drops and ointment

208

Piracetam

Oral administration: various forms

209

Piroxicam

...

...

...

210

Policresulen (Metacresolsulphonic acid-formaldehyde)

Topical administration

Rectal tablets

211

Polymethylen glycol 400 of pure form or mixed with Propylen glycol

Eye drops and ointment

...

...

...

212

Polysacharid

Oral administration: various forms

213

Polytar of pure or mixed form in topical finished products (as Zinc Pyrithion ...)

Topical administration

...

...

...

Povidon Iodin

Topical administration: various forms, including mouthwash with concentration ≤ 1%.

Eye drops and ointment

215

Promethazin HCl of pure or mixed in finished products of cough, antipyretic and analgesic drug (with Carbocystein; Paracetamol ...)

Oral administration: various forms with limited contents and concentration of Promethazin (by base form) as follows:

-Divided dosage ≤ 12.5mg/unit;

- Undivided dosage ≤ 0.1%

...

...

...

216

Pseudoephedrin HCl mixed with Cetirizin

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage ≤ 120mg/unit;

- Undivided dosage ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

217

Pseudoephedrin HCl mixed in finished products of cough, antipyretic and analgesic drug

...

...

...

- Divided dosage ≤120mg/ unit;

- Undivided dosage ≤ 0,5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

218

Pyrantel

Oral administration: various forms

Indication: worm treatment

219

Ranitidine

...

...

...

To be sold without prescription for up to 15 days of use

220

Rotundin of pure form or mixed with herbal extract and glue

Oral administration: various forms

221

Rotundin of pure form or mixed with Vitamin C and/or herbal extract and glue

Oral administration: various forms

...

...

...

Saccharomyces boulardic

Oral administration: various forms

223

Saccharomyces cerevisiae + Trihydrat Magnesi Sulfat

Oral administration: various forms

224

Hyocine (Scopolamin) butylbromid of pure form or mixed with Meclizin hydrochlorid

...

...

...

Oral administration: various forms, including the chewable tablets with limited content of divided dosage ≤ 20mg

Dermal patch

225

Organic selenium of mixed form in finished products containing Vitamin and minerals

Oral administration: various forms with limited content as follows:

- Selen with divided dosage ≤ 50mcg/ unit

226

...

...

...

Topical administration

227

Silymarin of pure form or mixed with Vitamins and/or herbal extract and glue

Oral administration: various forms

228

Simethicone of pure form or mixed with Pancreatin and / or Desoxycholic acid and / or vitamin of group B and / or digestive enzymes

Oral administration: various forms

...

...

...

229

Simethicon mixed with the aluminum compound, magnesium, and / or dicyclomine and / or activated carbon

Oral administration: various forms

230

Sorbitol of pure or mixed form

Oral administration: various forms

231

...

...

...

Oral administration: various forms

Drug of rectal enema

232

Sucralfate

Oral administration: various forms

233

Sulbutiamine

...

...

...

234

Sulfogaiacol of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as mixed with Sodium benzoate, Dextromethophan ...)

Oral administration: various forms

235

Terbinafine

Topical administration: various forms with concentration ≤ 1%

...

...

...

Terpin of pure form or mixed with Codeine

Oral administration: various forms.

Mixed form of Codeine (by base form) with limited content as follows:

- Divided dosage ≤ 30mg/unit;

- Divided dosage ≤ 2.5%

Finished products containing Codeine are sold without prescription with a maximum amount for 10 days of use.

237

Tetrahydrozoline

...

...

...

238

Activated carbon of pure form or mixed with Simethicone

Tioconazol of pure form or mixed with Hydrocortisone

Oral administration: various forms

Topical administration: various forms with concentration as follows:

- Tioconazol ≤ 1.00%

- Hydrocortison ≤ 0.05%

...

...

...

239

Tolnaftate

Topical administration

240

Tretinoin

Topical administration: various forms with concentration ≤ 0.05%

241

...

...

...

Topical administration

242

Triprolidine of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as with Guaiphenesin, Paracetamol, Pseudoephedrin HCl, Dextromethophan HBr...)

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage ≤120mg/ unit;

- Undivided dosage ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

...

...

...

Trolamine of pure or mixed form in topical finished products (with Triclosan and/or Tyrothricin)

Topical administration

244

Tyrothricin of mixed form (with Benzalkonium, Benzocain, Formaldehyd, Trolamin, essential oil...)

Oral administration: lozenge

Topical administration: Mouthwash and mouth spray

...

...

...

Urea of pure form or mixed with Vitamin E and/or Bifonazol and/or medicinal materials (Aloe glue)

Topical administration

246

Vitamin A and provitamin A (Betacaroten)

Oral administration: various forms with Vitamin A ≤ 5000 IU /dosage unit

Topical administration

Eye drops and ointment

...

...

...

Vitamin of group B, Vitamin PP of pure or mixed form

Eye drops and ointment

248

Vitamin and provitamin of pure form (excluding Vitamin A and Article) or mixed with Vitamins, minerals, amino acids, Taurine, fatty acid.

Oral administration: Vitamin A of mixed form ≤ 5000 IU/dosage unit

Topical administration  

With the effect of supplemental vitamins, minerals and nutrients.

249

...

...

...

Topical administration  

250

Xylometazolin of pure form or mixed with Benzalkonium. 

Nose drug with concentration of Xylometazolin ≤ 1%

2. LIST OF DRUGS ORIGINATED FROM MEDICINAL MATERIALS:

Drugs originated from medicinal materials whose ingredients do not contain high toxic medicinal materials (Ex: nux vomica, monkshood, gelsemium elegans benth, nerium oleander, strychnos wallichiana steud,…) or medicinal materials having serious adverse effects known/warned of these effects are classified as OTC drugs;

Drugs originated from medicinal materials whose ingredients contain high toxic medicinal materials (Ex: nux vomica, monkshood, gelsemium elegans benth, nerium oleander, strychnos wallichiana steud,…) or medicinal materials having serious adverse effects known/warned of these effect are classified according to each specific case;