Label: ANTIFUNGAL CREAM TOLNAFTATE 1%- tolnaftate cream
- NDC Code(s): 79481-0015-5
- Packager: Meijer
- 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 January 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
- When using this product
- Do Not Use
- Stop Use and Ask a Doctor if
- If Pregnant or Breast-feeding
- Inactive ingredients
-
Directions
● wash affected area and dry thoroughly
● apply a thin layer over 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: pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.
● for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult 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.
- Other information
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL CREAM TOLNAFTATE 1%
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0015 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 CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0015-5 1 in 1 BOX 05/12/2021 1 14 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 05/12/2021 Labeler - Meijer (006959555) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
