Label: CR-371059 TOLNAFTATE 1% cream

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

Drug Label Information

Updated November 1, 2023

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

    • Helps prevent most athlete's foot with daily use

    • For effective relief of itching, burning, and cracking

  • Warnings

    • For External Use Only

    • This product is not effective on the scalp or nails

    When using this product

    Avoid contact with the eyes

    Stop use and ask a doctor if

    • Irritation occurs

    • There is no improvement within 4 weeks

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away

    • Do not use on children under 2 years of age except under the advice and supervision of a doctor

  • Directions

    • Wash affected area and dry thoroughly

    • Apply a thin layer over affected area twice daily (morning and night)

    • Supervise children in the use of this product

    • For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks

    at least once daily

    • Use daily for 4 weeks; if condition persists longer, ask a doctor

    • To prevent athlete's foot, apply once or twice daily (morning and/or night)

  • Other Information

    Store between 20° to 25ºC (68º to 77ºF)

  • Inactive Ingredients

    Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

  • Questions and Comments?

    1-800-645-2158

  • HOW SUPPLIED

    Product: 50090-6147

    NDC: 50090-6147-0 14.8 g in a TUBE

  • TOLNAFTATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    CR-371059 TOLNAFTATE 1% 
    cr-371059 tolnaftate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6147(NDC:0536-1315)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-6147-014.8 g in 1 TUBE; Type 0: Not a Combination Product10/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/01/2021
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-6147)
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