TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]

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  • TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]

TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]
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NDC 51672-2080-1, 51672-2080-2, 51672-2080-3, 51672-2080-4, 51672-2080-6, 51672-2080-8, 51672-2080-9
Set ID 92b31fc4-0f02-4857-b11f-49b9f942ee84
Category HUMAN OTC DRUG LABEL
Packager Taro Pharmaceuticals U.S.A., Inc.
Generic Name
Product Class Allylamine Antifungal
Product Number
Application Number ANDA077511
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  • 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 eyes
    • for vaginal yeast infections

    When using this product do not get into 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.

  • Directions

    • adults and children 12 years and over:
      • 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
    		Image 1 week between the toes Image 2 weeks on the bottom or sides of the foot
  • Other information

    TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.

    • store at controlled room temperature 20° to 25°C (68° to 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

  • Questions?

    call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    NDC 51672-2080-2
    Full Prescription Strength

    FOR ATHLETE'S FOOT

    Terbinafine Hydrochloride
    Cream 1%
    Antifungal

    NET WT 1 oz (30 g)

    Principal Display Panel - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2080-11 in 1 CARTON07/02/2007
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-2080-21 in 1 CARTON07/02/2007
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51672-2080-81 in 1 CARTON07/02/2007
    312 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51672-2080-91 in 1 CARTON07/02/2007
    424 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:51672-2080-61 in 1 CARTON07/02/2007
    545 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:51672-2080-31 in 1 CARTON07/02/2007
    660 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:51672-2080-41 in 1 CARTON04/24/2017
    715 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07751107/02/2007
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2080)
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