Label: UP AND UP ANTIFUNGAL- tolnaftate 1% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2024

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  • DRUG FACTS 

  • Active ingredient

    Tolnaftate 1%

  • Purpose 

    Antifungal 

  • Uses

    • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • for effective relief of itchy, scaly skin between the toes
    • clears up most athlete's foot infection and with daily use helps keep it from coming back
  • Warnings

    For external use only

  • Do not use

    • on children under 2 years of age unless directed by a doctor
  • When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • 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 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

    • use daily for 4 weeks. If condition persists longer, consult a doctor
    • pay special attention to the spaces between the toes
    • wear well fitting ventilated shoes
    • change shoes and socks at least once daily

    For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
    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 20° -25°C (68-77°F)

  • Inactive ingredients

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

  • Questions or comments? call 1-800-910-6874

  • Principal display panel

    Up &Up                NDC 82442-020-28

    Antifungal Cream 

    Tolnaftate 1%

    NET WT 1 OZ (28g)

    591060_Target_Antifunal_Carton

    291060_Target_Antifunal_Tube

  • INGREDIENTS AND APPEARANCE
    UP AND UP ANTIFUNGAL 
    tolnaftate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82442-020
    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, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82442-020-281 in 1 CARTON08/01/2024
    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 DrugM00508/01/2024
    Labeler - Target Corporation (006961700)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(82442-020) , analysis(82442-020)
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