Label: KAISER PERMANENTE TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream

  • NDC Code(s): 0179-8715-30
  • Packager: Kaiser Foundation Hospitals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 19, 2013

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Terbinafine hydrochloride 1%

    Close
  • Purpose

    Antifungal

    Close
  • Uses

    • cures most athlete's foot (tinea pedis)
    • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, burning, cracking and scaling which accompany these conditions
    Close
  • Warnings

    For external use only

    Do not use

    • on nails or scalp
    • in or near the mouth or the eyes
    • for vaginal yeast infections

    When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    • too much irritation occurs or gets worse.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    Close
  • Directions

    • adults and children 12 years and older
      • use the tip of the cap to break the seal and open the tube
      • wash the affected skin with soap and water and dry completely before applying
      • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
        • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
        • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
      • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
      • wash hands after each use
    • children under 12 years: ask a doctor
    1 week between the toes
    Image
    2 weeks on the bottom
    or sides of the foot
    Image
    Close
  • Other information

    • do not use if seal on tube is broken or is not visible
    • store at controlled room temperature 20°-25°C (68°-77°F)
    • see carton or tube crimp for lot number and expiration date
    Close
  • Inactive ingredients

    benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

    Close
  • Questions?

    Call 1-866-923-4914

    Close
  • SPL UNCLASSIFIED SECTION

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

    Close
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    KAISER PERMANENTE®

    Terbinafine Hydrochloride Cream 1%
    ANTIFUNGAL CREAM
    CURES MOST ATHLETE'S FOOT

    Compare to the active ingredient in Lamisil AT®*

    NET WT 1 OZ (30 g)

    Principal Display Panel - 30 g Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    KAISER PERMANENTE   TERBINAFINE HYDROCHLORIDE
    terbinafine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0179-8715
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0179-8715-30 1 in 1 CARTON
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077511 07/02/2007
    Labeler - Kaiser Foundation Hospitals (053052619)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0179-8715)
    Close