Label: EQUATE ATHLETES FOOT- tolnaftate cream
- NDC Code(s): 49035-252-42
- Packager: WALMART STORES INC
- Category: HUMAN OTC DRUG LABEL
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 August 17, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
For athlete's foot
- use daily for 4 weeks. If condition persists longer, consult a doctor
- pay special attention to the spaces between the toes
- wear well fitting ventilated shoes
- change shoes and socks at least once daily
For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
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.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
EQUATE ATHLETES FOOT
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-252 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) CHLOROCRESOL (UNII: 36W53O7109) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-252-42 1 in 1 CARTON 08/31/2016 1 28 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 08/31/2016 Labeler - WALMART STORES INC (051957769) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(49035-252)