Label: THERA PLUS ANTIFUNGAL TOLNAFTATE- tolnaftate cream
- NDC Code(s): 80684-040-01
- Packager: FOURSTAR GROUP USA, INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 26, 2023
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- Drug Facts
- Active ingredient
- 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-ftting, ventilated shoes and change shoes and socks at least once daily
- use daily for 4 weeks ; if condition 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.
- Other information
- Inactive ingredients
- Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
THERA PLUS ANTIFUNGAL TOLNAFTATE
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80684-040 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 CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80684-040-01 1 in 1 BOX 01/30/2022 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 Drug M005 01/30/2022 Labeler - FOURSTAR GROUP USA, INC. (140099503)