Label: ATHLETES FOOT- clotrimazole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72103-527-10 - Packager: The IBN SINA Pharmaceutical Industry Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 14, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
ATHLETES FOOT
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72103-527 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:72103-527-10 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(72103-527)
