SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]

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SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]
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NDC 50066-080-02, 50066-080-03, 50066-080-05
Set ID a32cf699-e63e-4bd3-a5af-9e1ba447e02e
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, 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 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.

  • 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.
  • Other information

    • do not use if seal on tube is broken or is 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?

    1 877 99 GENOM (43666) Monday to Friday, 8 am to 6 pm Central time.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Genomma Lab USA Inc., Houston, TX, 77027

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    FULL PRESCRIPTION
    STRENGTH

    SILKA®
    Terbinafine Hydrochloride Cream 1%

    ANTIFUNGAL CREAM

    CURES MOST ATHLETE'S FOOT

    NET WT. 1oz (30 g)

    Principal Display Panel - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SILKA   ANTIFUNGAL
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine1 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:50066-080-021 in 1 CARTON07/02/2007
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50066-080-031 in 1 CARTON05/21/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50066-080-051 in 1 CARTON12/20/2018
    315 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 - Genomma Lab USA, Inc. (832323534)
    Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(50066-080)
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