Label: WINCO ANTIFUNGAL- tolnaftate 1% cream

  • Category: HUMAN OTC DRUG LABEL

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 April 6, 2022

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  • Drug Facts 

  • Active 

    Tolnaftate 1% 

  • Purpose 

    Antifungal 

  • 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.
  • Inactives 

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

  • Questions ?

    1-800-222-1087

  • Principal Display panel -Carton 

    WINCO                                    NDC 67091-051-28

    Antifungal Cream (Tolnaftate 1%) 

    CURES Most:

    ATHLETE'S

    FOOTJOCK ITCH

    RINGWORM

    NET WT. 1.0 OZ (28 g)

    557175_Winco_1oz_Tolnaftate_Carton.jpg

  • Principal Display Panel -Tube

    WINCO NDC 67091-051-28

    Antifungal Cream (Tolnaftate 1%)

    CURES Most:

    ATHLETE'S

    FOOTJOCK ITCH

    RINGWORM

    NET WT. 1.0 OZ (28 g)

    255125_Winco_1oz_Tolnaftate_Tube.jpg

  • INGREDIENTS AND APPEARANCE
    WINCO ANTIFUNGAL 
    tolnaftate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-051
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-051-281 in 1 CARTON04/30/2022
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/30/2022
    Labeler - WinCo Foods LLC (056098817)