NDC | 72103-526-10 |
Set ID | 8412b59b-ec6e-5091-e053-2991aa0a8f29 |
Category | HUMAN OTC DRUG LABEL |
Packager | The IBN SINA Pharmaceutical Industry Ltd. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- wash the affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot:
- pay special attention to the spaces between the toes
- wear well-fitting ventilated shoes
- change shoes and socks at least once daily
- for athlete's foot and ringworm: use daily for 4 weeks
- for jock itch: use daily for 2 weeks
- if condition persists longer, consult a doctor
- this product is not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RINGWORM
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72103-526 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72103-526-10 1 in 1 CARTON 03/14/2019 1 10 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/14/2019 Labeler - The IBN SINA Pharmaceutical Industry Ltd. (731557752) Establishment Name Address ID/FEI Business Operations The Ibn Sina Pharmaceutical Industry Ltd. 731557752 manufacture(72103-526)