Label: TOLNAFTATE ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 51672-2020-1, 51672-2020-2
- Packager: Taro Pharmaceuticals U.S.A., 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 January 31, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- 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 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
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INGREDIENTS AND APPEARANCE
TOLNAFTATE ANTIFUNGAL
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2020 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 butylated hydroxytoluene (UNII: 1P9D0Z171K) polyethylene glycol 400 (UNII: B697894SGQ) polyethylene glycol 3350 (UNII: G2M7P15E5P) titanium dioxide (UNII: 15FIX9V2JP) petrolatum (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (opaque, white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2020-1 1 in 1 CARTON 01/01/1995 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51672-2020-2 1 in 1 CARTON 01/01/1995 2 30 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 01/01/1995 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2020)