KAISER PERMANENTE TOLNAFTATE (TOLNAFTATE) CREAM [KAISER FOUNDATIONS HOSPITALS]

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  • KAISER PERMANENTE TOLNAFTATE (TOLNAFTATE) CREAM [KAISER FOUNDATIONS HOSPITALS]

KAISER PERMANENTE TOLNAFTATE (TOLNAFTATE) CREAM [KAISER FOUNDATIONS HOSPITALS]
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NDC 0179-8019-30
Set ID 603fd22b-1f82-4eb3-b956-1022c87776ee
Category HUMAN OTC DRUG LABEL
Packager Kaiser Foundations Hospitals
Generic Name
Product Class
Product Number
Application Number PART333C
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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

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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)
    • this product is not effective on the scalp or nails
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
    Distributed by
    Kaiser Foundation Hospitals, Livermore, CA 94551-9756

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    KAISER PERMANENTE ®

    Tolnaftate Cream 1%

    ANTIFUNGAL CREAM

    CURES & PREVENTS MOST ATHLETE'S FOOT

    *Compare to the active ingredient in Tinactin ®

    NET WT 1 OZ (30 g)

    Principal Display Panel - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KAISER PERMANENTE  TOLNAFTATE
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8019
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0179-8019-301 in 1 CARTON02/17/200603/31/2022
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/17/200603/31/2022
    Labeler - Kaiser Foundations Hospitals (053052619)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(0179-8019)
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