Label: ATHLETES FOOT ANTIFUNGAL ANTIFUNGAL- clotrimazole cream
- 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.
Updated July 25, 2020
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- Active ingredients
- Keep out of reach of children
This product is not effective on the scalp or nails
- clean the affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor. Pay special attention between the toes. Wear well fitting, ventilated shoes and change shoes and socks at least once a day.
- supervise children in the use of this product
- use daily for 4 weeks
- if condition persists longer, ask a doctor
- Other information
- Inactive ingredients
Clotrimazole USP 1%
Cures most major types of athlete's foot
NET WT. 1.25 OZ. (35 g)
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Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.
Code No. MH/DRUGS/KD-313 Made in India
INGREDIENTS AND APPEARANCE
ATHLETES FOOT ANTIFUNGAL ANTIFUNGAL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2435 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 350 mg in 35 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITAN TRISTEARATE (UNII: 6LUM696811) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-2435-1 35 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/10/2013 Labeler - Personal Care Products, Inc. (966155082) Registrant - Personal Care Products, Inc. (966155082) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd. 916837425 manufacture(29500-2435)