Label: THERACARE ANTIFUNGAL CREAM- 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 June 30, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically 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

    Do not use on children under 2 years of age unless directed by a doctor

    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 Poison Control Center right away. (1-800-222-1222)

  • Directions

    adults and children 2 years of age and over:

    • 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
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails

    Children under 2 years of age: consult a physician

  • Other information

    store between 20° to 25°C (68° to 77°F)

    • do not use if tube seal under cap is broken
  • Inactive ingredients

    ceteth-20, cetostearyl alcohol, cetyl alcohol, chlorocresol, light mineral oil, petrolatum, propylene glycol, sodium phosphate, sodium phosphate dibasic monohydrate, water

  • Questions?

    Toll Free 1-866-326-1313

  • PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

    Packlabel

  • INGREDIENTS AND APPEARANCE
    THERACARE ANTIFUNGAL CREAM 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-934
    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)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Product Characteristics
    Colorwhite (White to Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-934-011 in 1 CARTON06/01/2022
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2022
    Labeler - Veridian Healthcare (830437997)
    Registrant - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-934)
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