Arab Republic of Egypt ‫جمهورية مصر العربية‬

Egyptian Drug Authority ‫هيئة الدواء المصرية‬

CA of Pharmaceutical Care
‫اإلدارة المركزية للرعاية الصيدلية‬
The Egyptian Non-prescription Medicinal Products (OTC) List
No. Generic name Dosage form or Route Notes
1 Aceclofenac Topical

2 Minerals Oral,topical

• Accepted within daily dietary intake in multi-ingrediant products,

3 Vitamin A Oral, topical
• in case single product with high doses and for specific indication it should be POM

• Accepted within daily dietary intake in multi-ingrediant products,

4 Vitamin D Oral, topical
• in case single product with high doses and for specific indication it should be POM

• Accepted within daily dietary intake in multi-ingrediant products,

5 Vitamin E Oral, topical
• in case single product with high doses and for specific indication it should be POM

• Accepted within daily dietary intake in multi-ingrediant products,

6 Vitamin K Oral, topical
• in case single product with high doses and for specific indication it should be POM

7 Vitamin B Oral, topical

8 Vitamin C Oral, topical

9 Aluminium Hydroxide Oral • Adequately labeling mentioning impaired renal function precautions

10 Ambroxol Oral

11 Antazoline Topical

Aspirin
12 (75,81,100,150,162,250, Oral • Concantrations above 325mg POM
300,320,325)

13 Benproperine Oral • May cause dizziness

• Adequate labeling mentioning Methemoglobinemia warning.

• Used only in the following age groups:
Topical spray, Oral spray & gel & - Dental gel: From 2 years, only with medical supervisio
14 Benzocaine
lozenges - Oral solution: From 6 years
- Dental spray: From 6 years
- Lozenges: From 12 years

15 Bisacodyl Oral, rectal

16 Bromhexine Oral

• Use of this drug is completely prohibited in children less than 2 years.

17 Brompheniramine Oral • Use of this drug is prohibited in children less than 6 years without medical
supervision.

18 Butenafine Topical

19 Caffeine Oral • In combination products only.

20 Calamine Topical

Calcium carbonate, • Caution should be generally exercised in the case of patient with impaired renal
21 Oral
Magnesium carbonate function.

22 Camphor Topical

• Contraindicated in patients less than 2 years.

23 Carbinoxamine Oral
• Antihistamines may cause drowsiness. Use caution when driving or using machine.

24 Carboxymethylcellulose Eye drops

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Arab Republic of Egypt ‫جمهورية مصر العربية‬

Egyptian Drug Authority ‫هيئة الدواء المصرية‬
CA of Pharmaceutical Care
‫اإلدارة المركزية للرعاية الصيدلية‬
The Egyptian Non-prescription Medicinal Products (OTC) List
No. Generic name Dosage form or Route Notes
• Contraindicated in infants less than 6 month.
• In chronic conditions, it should be used under medical supervision.
25 Cetirizine Oral
• May cause drowsiness; Use caution when driving a motor vehicle or operating
machinery

26 Chlorhexidine Gluconate Topical

• Use of this drug is completely prohibited in children less than 2 years. Use of this
drug is prohibited in children less than 6 years without medical supervision.
Chlorpheniramine
27 Oral • May cause drowsiness; caution when driving a motor vehicle or operating
Maleate
machinery.
• In chronic cases, it must be used under medical supervision.

28 Cinchocaine Topical

29 Citric Acid Oral

• Sedation side effects should be clearly labeled.

30 Clemastine Oral
• In chronic conditions, it must be used under medical supervision.

31 Clotrimazole Topical

32 Cromoglicic acid Nasal

• Must not be used in children under 2 years unless directed by a doctor. (to include
33 Cromolyn sodium Nasal
or to not include age limits)

34 Crotamiton Topical

• Sedation side effects should be clearly labeled

35 Cyproheptadine Oral
• Take care in geriatric because of atropine like effects.

36 Desloratadine Oral • Antihistamines may cause drowsiness. Use caution when driving or using machine.

• Antihistamines may cause drowsiness. Use caution when driving or using machine.
37 Dexbrompheniramine Oral
• In case of chronic cases, it must be used under medical supervision.

• Sedation side effects should be clearly labeled (daily med)

38 Dexchlorpheniramine Oral
• In case of chronic cases, it should be used under medical supervision.

39 Dexpanthenol Topical

40 Diclofenac Sodium Topical

41 Dicyclomine Oral

• Adequately labeling mentioning impaired renal function precautions

42 Dihydroxy Aluminum Oral • Used with extreme caution and only in necessary cases of ascites resulting from
liver failure, hypertensive patients and heart diseases.

43 Dimethicon Oral & Topical

• Antihistamines may cause drowsiness. Use caution when driving or using machine.
• Sedation side effects should be clearly labeled
• Not used in children less than 1 year.
44 Dimetindene maleate Oral & Topical • Topical anti-histaminic may cause hypersensitivity; avoid in eczema;
photosensitivity
Not recommended for longer than 3 days

• Sedation side effects should be clearly labeled.

• Topical anti-histaminic may cause hypersensitivity; avoid in eczema; Not
45 Diphenhydramine Oral & Topical recommended for longer than 3 days in photosensitivity
• Use of this drug is completely prohibited in children less than 2 years. Use of this
drug is prohibited in children less than 6 years without medical supervision.

46 Docosanol Topical

47 Domiphen bromide Oral

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Arab Republic of Egypt ‫جمهورية مصر العربية‬

Egyptian Drug Authority ‫هيئة الدواء المصرية‬
CA of Pharmaceutical Care
‫اإلدارة المركزية للرعاية الصيدلية‬
The Egyptian Non-prescription Medicinal Products (OTC) List
No. Generic name Dosage form or Route Notes

• In chronic cases, it should be used under medical supervision.

• May cause drowsiness. Use caution when driving or using machinery.
48 Doxylamine succinate Oral • Use of this drug is completely prohibited in children less than 2 years. Use of this
drug is prohibited in children less than 6 years without medical supervision
• Use of this drug in pregnancy is prohibited as it may cause birth defects.

• In chronic cases, it should be used under medical supervision.

• May cause drowsiness. Use caution when driving or using machinery.
Doxylamine succinate,
49 Oral • Use of Doxylamine is completely prohibited in children less than 2 years. Use of
Caffeine
this drug is prohibited in children less than 6 years without medical supervision
• Use of Doxylamine in pregnancy is prohibited as it may cause birth defects.

50 Etofenamate Topical

51 Fexofenadine Oral • Not used in children less than 2 years.

52 Folic acid Oral (< 1 mg)

• Use of this drug is completely prohibited in children less than 2 years. Use of this
53 Guaifenesin Oral & rectal
drug is prohibited in children less than 6 years without medical supervision.

54 Hexetidine Mouth Wash

55 Hydrocortisone Topical Prolonged use of corticosteroids may increase the incidence of secondary infection.

56 Hyoscine Oral

57 Ibuprofen Topical

58 Indomet(h)acin Topical (maximum strength 1 %)

• In combinations only
59 Iron Oral
• ADR: Constipation, darkening of stools, Dental discoloration, Urine discoloration.

60 Lactulose Oral

Lidocaine 2 % products are not approved to treat teething pain as use in infants and
61 Lidocaine Topical
young children can cause serious harm, including death
• In chronic cases, it should be used under medical supervision.
62 Loratadine Oral
• May cause drowsiness. Use caution when driving or using machinery.
lysosyme HCl ,
63 Lozenges
Dequalinium Chloride

64 Magaldrate Oral

65 Magnesium Hydroxide Oral

66 Magnesium Trisilicate Oral

67 Mebevirin Oral

• The use of this drug is contraindicated in children under 2 years of age, and in
68 Meclizine Oral & rectal
children 2-12 years is allowed only under medical supervision.

69 Menthol Topical

• For the oral dosage forms:

70 Mepyramine maleate Oral & Topical 1- In chronic cases, it should be used under medical supervision.
2- May cause drowsiness. Use caution when driving or using machinery.

71 Methyl salicylate Topical

Topical & Oral Gel

72 Miconazole
(Maximum strength 2%)

73 Minoxidil sulphate Topical only except gel • Maximum strength 5% for use as OTC

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Arab Republic of Egypt ‫جمهورية مصر العربية‬

Egyptian Drug Authority ‫هيئة الدواء المصرية‬
CA of Pharmaceutical Care
‫اإلدارة المركزية للرعاية الصيدلية‬
The Egyptian Non-prescription Medicinal Products (OTC) List
No. Generic name Dosage form or Route Notes
• Treatment duration should not exceed 5 days; frequent or prolonged use may cause
nasal congestion to recur or worsen.
Nasal (Maximum strength 0.05%) [FDA & technical committee decision]
74 Naphazoline & Ophthalmic (Maximum strength •As a single agent it should not be used in children <12 years as a single agent
0.015%) • As a combination product with prednisolone it should not be used in children < 15
years.

75 Naproxen Topical

76 Nicotine Oral Gum

• Take care of risk of infection (STD)

77 Nonoxynol-9 Vaginal suppository
Std: Sexually transmitted disease.

78 Noscapine Oral • Maximum single dose 30mg, maximum daily dose 150mg.

79 Oral rehydration salts powder for oral solution

80 Oxetacaine Oral • Maximum dose 10mg , Maximum daily dose 30mg

• Treatment duration should not exceed 3 days; frequent or prolonged use may cause
nasal congestion to recur or worsen.
81 Oxymetazoline Nasal
• used for adults and children over12 years of age
• Maximum Strenght 0.05% &0.025%
All dosage forms except for:
[Link] release tablets • Adequately labeling mentioning hepatitis warning
82 Paracetamol
[Link] release tablets • Maximum dose 1g, maximum daily dose [Link] adult& conc 500mg , 1gm
[Link]
Topical only
1% shampoo Anti-lice • leave on hair for 10 min ( but no longer), use for a single application but may
83 Permethrin
2.5% cream , emulsion, lotion , repeat 7 days after first treatment if lice still present ( uptodate)
ointment Anti-scabies

• Not use in children less than 6 years , present in EDA as oral combinations but
84 phenylephrine oral
present as single component eye drops, ear , ophthamic

Pheniramine
• May cause drowsiness, caution should be taken when driving or operating
85 maleate,Ammonium Oral
machinery.
chloride

• Short term use only, Maximum dose 7.5mg per day as sodium picosulfate hydrate
for adults and adolescents 15 years of age and over. For children between 11 and 14,
86 Picosalphate (Na) Oral drops , tablets maximum dose 4.5mg per [Link] sale if for adults and children over 10 years.
Maximum strength 0.1%, maximum dose 15mg, maximum daily dose 15mg,
(AESGP)

87 Piperonyl butoxide Topical only

• Maximum strength 0.5% in adults and children over 12 years, for a maximum of 7
88 Piroxicam Topical only
[Link]. , AESGP
• Can’t be used for more than 7 consecutive days, Indicated in temporary
89 Polyethylene glycol 3350 Oral
constipation in adults and children over 6 months.(france AESGP)

90 Polymyxin B Topical only

91 Povidone-Iodine Topical only

92 Pramocaine Topical only

• Use is completely prohibited in children < 2 years, Use in children <6 years must
93 Promethazine Oral
only be under medical supervision

94 Propanthelin Topical only

Page 4 of 6


Arab Republic of Egypt ‫جمهورية مصر العربية‬

Egyptian Drug Authority ‫هيئة الدواء المصرية‬
CA of Pharmaceutical Care
‫اإلدارة المركزية للرعاية الصيدلية‬
The Egyptian Non-prescription Medicinal Products (OTC) List
No. Generic name Dosage form or Route Notes
- 30 mg/5ml:
Contraindicated in children less than 12 years old.
-15 mg/5ml:
95 Pseudoephedrine Oral only
Contraindicated in pediatrics less than 2 years old and from 2-12 years old used
under medical supervision.

Psyllium Muciloid
96 Oral • Administration precautions should be adequately labeled
(Ispaghula)

97 pyrethrins Topical

Oral , Powder,hard gelatin

98 Racecadotril capsules,sachets(granules for oral
suspension)

99 Selenium Oral tablets • Only in Combination

Oral(Chewable tablets
100 Simethicon
,suspension,oral drops)
Only in Combination
‫يستخدم بحذر للمرضى المطلوب منهم اإلقالل من استخدام الصوديوم ) الملح ( مثل مرضى ضغط الدم‬
101 Sodium Bicarbonate Oral
‫ومرضى القلب والفشل الكلوي واالستسقاء الناتج عن‬
‫الفشل الكبدي‬
nasal spray ,nasal gel & opthalmic
102 Sodium Chloride
solution as eye drops

• Maximum strength 2%
103 Sodium Chromoglicate Eye drops • OTC indication: only for the relief and treatment of seasonal and perennial allergic
conjunctivitis

Topical ( Cream,gel,topical
104 Terbinafine
solution, spray)
• For painful ulcer.
105 Triamcinolne oral base Oral paste
• OTC only in those aged 18 years and over.

106 Tribneoside Topical

• Contraindicated in children less than 2 years.

• Must be used under medical supervision in children less than 6 years.
• Must be used under medical supervision in chronic cases.
107 Triprolidine Oral(Tablets ,syrup)
• Antihistamines may cause drowsiness. Use caution when driving or using
machinery.
• Take care in geriatric because of atropine like effects.
• Maximum strength : up to 0.1%
108 Xylometazoline Nasal drops • Prohibited in children < 6 years, and
• pharmacology warning.

109 Zinc Sulphate Oral

Miconazole Nitrate 2%
110 Hydrocortisone Topical
Micronized 1% Cream
Fexofenadine
Hydrochloride 60mg
111 Oral • Used only in those aged 2 years and over.
+Pseudoephedrine
Hydrochloride 120mg
Bacillus Clausii spores 2
112 Oral
Billion/5ml
Paracetamol 500 mg
113 Oral
Caffeine 65mg
Sodium alginate
500mg/10ml, Sodium
• Use with caution in patients on sodium-restricted diet for example in patients with
114 Bicarbonate Oral sachet
hypertension, heart disease, renal failure and ascites from hepatic failure.
267mg/10ml, Calcium
Carbonate 160mg/10ml

Sodium alginate
• Use with caution in patients on sodium-restricted diet for example in patients with
115 500mg/5ml, Sodium Oral suspension
hypertension, heart disease, renal failure and ascites from hepatic failure.
Bicarbonate 100mg/5ml

Page 5 of 6


Arab Republic of Egypt ‫جمهورية مصر العربية‬

Egyptian Drug Authority ‫هيئة الدواء المصرية‬
CA of Pharmaceutical Care
‫اإلدارة المركزية للرعاية الصيدلية‬
The Egyptian Non-prescription Medicinal Products (OTC) List
No. Generic name Dosage form or Route Notes
Sodium alginate 250mg,
Sodium Hydrogen • Use with caution in patients on sodium-restricted diet for example in patients with
116 Oral Chewable Tablets
carbonate 133.5, hypertension, heart disease, renal failure and ascites from hepatic failure.
Calcium carbonate 80mg
Beta-Sitosterol
117 Topical ointment
0.25g/100g

Page 6 of 6