Label: TOLNAFTATE cream

  • 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 March 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate USP 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 15°-30°C (59°-86°F)
    • Lot No. and Exp date: see crimp on tube or see box
  • Inactive ingredients

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

  • Questions?

    Adverse Drug Event call (800)616-2471

    Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

    Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

  • HOW SUPPLIED

    Product: 50090-0160

    NDC: 50090-0160-0 14.18 g in a TUBE / 1 in a CARTON

  • TOLNAFTATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0160(NDC:0904-0722)
    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:50090-0160-01 in 1 CARTON11/28/2014
    114.18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/11/2010
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0160)
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