Label: SUNMARK ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 49348-155-29
- Packager: Strategic Sourcing Services LLC
- 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 November 26, 2019
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- Download DRUG LABEL INFO: PDF XML
- 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
- this product is not effective on scalp or nails
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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INGREDIENTS AND APPEARANCE
SUNMARK ANTIFUNGAL
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-155 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 Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Polyethylene Glycol 400 (UNII: B697894SGQ) Polyethylene Glycol 3350 (UNII: G2M7P15E5P) titanium dioxide (UNII: 15FIX9V2JP) petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-155-29 1 in 1 CARTON 02/13/2013 1 15 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 02/17/2006 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-155)