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Terbinafine Hydrochloride (Physicians Total Care, Inc.)

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Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (54868-5992-0) > 30 g in 1 TUBE Label Information

Complete Terbinafine Hydrochloride Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Terbinafine hydrochloride 1%


  • Purpose

    Antifungal


  • 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

  • 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.
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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


  • 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
    Figure 1
    2 weeks on the bottom or sides of the foot
    Figure 2

  • 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

  • Inactive ingredients

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


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146


  • PRINCIPAL DISPLAY PANEL - 30 g Carton

    Cures Most Athlete's Foot

    carton

    Terbinafine Hydrochloride
    Cream 1%
    Antifungal Cream

    Full Prescription Strength

    NET WT 1 oz (30 g)

    Principal Display Panel - 30 g Carton

  • INGREDIENTS AND APPEARANCE
    TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5992(NDC:51672-2080)
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 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:54868-5992-0 1 in 1 CARTON
    1 30 g in 1 TUBE
    2 NDC:54868-5992-1 1 in 1 CARTON
    2 15 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077511 02/24/2009
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel(54868-5992)