Label: ANTIFUNGAL- tolnaftate 1% cream
- NDC Code(s): 63868-685-01
- Packager: Chain Drug Marketing Association Inc.
- 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 May 23, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Keep out of reach of children
- Uses
- Warnings
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Directions
● wash 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 spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.
● use daily for 4 weeks; if conditions persists longer, ask a doctor.
● to prevent athlete's foot, apply once or twice daily (morning and/or night)
● this product is not effective on the scalp or nails.
- Inactive ingredients
- Other information
- Distributed By
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL
tolnaftate 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-685 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-685-01 1 in 1 BOX 08/14/2020 1 28.3 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 08/14/2020 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)