Label: CR-371059 TOLNAFTATE 1% CREAM 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 November 18, 2022

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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

  • Label

    CR-371059 BX Master

  • INGREDIENTS AND APPEARANCE
    CR-371059 TOLNAFTATE 1% CREAM 
    cr-371059 tolnaftate 1% cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0536-1315-431 g in 1 BOX; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2021
    Labeler - Rugby Laboratories (079246066)
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