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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate USP 1%

  • Purpose

    Antifungal Cream

  • Uses

    • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
    • Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.
  • Warnings

    • Do not use on children under 2 years of age unless directed by a doctor.
    • For external use only avoid contact with eyes.
    • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • 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

    • Store at controlled room temperature 15°-30°C (59°-86°F).
    • Close cap tighty after ever use.
  • Inactive ingredients

    Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

  • Questions?

    1-800-222-1087

  • Principal Display Panel – 1.25 oz Tube

    Dr. Sheffield's NDC 11527-051-40

    Antifungal Cream (Tolnaftate 1%) Made in the USA

    CURES Most:

    ATHLETE'S

    FOOTJOCK ITCH

    RINGWORM                                 Net Wt. 1.25 OZ (35.4 g)

    Principal Display Panel – 1.25 oz Tube

    Principal Display Panel – 1.25 oz Tube

  • Principal Display Panel – 1.25 oz Carton

    Principal Display Panel – 1.25 oz Carton

    Dr. Sheffield's NDC 11527-051-40

    CURES Most:

    ATHLETE'S

    FOOTJOCK ITCH

    RINGWORM                                               Net Wt. 1.25 OZ (35.4 g)

    Principal Display Panel – 1.25 oz Carton

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-051-401 in 1 CARTON10/07/2009
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11527-051-511 in 1 CARTON10/07/2009
    214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/07/2009
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-051) , analysis(11527-051)