Label: TOLNAFTATE cream
- NDC Code(s): 11527-051-40, 11527-051-51
- Packager: Sheffield Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over the 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 the spaces between the toes.
- Wear well fitting ventilated shoes.
- Change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel – 1.25 oz Tube
- Principal Display Panel – 1.25 oz Carton
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INGREDIENTS AND APPEARANCE
TOLNAFTATE
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-051 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 WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) CHLOROCRESOL (UNII: 36W53O7109) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-051-40 1 in 1 CARTON 10/07/2009 1 35.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11527-051-51 1 in 1 CARTON 10/07/2009 2 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 10/07/2009 Labeler - Sheffield Pharmaceuticals LLC (151177797) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(11527-051) , analysis(11527-051)