TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]

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TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]
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NDC 63187-111-15, 63187-111-30
Set ID 76f7525d-2005-4da8-a795-50ede6236c68
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
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.
    •
    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

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL - 30 g Carton

    Cures Most Athlete's Foot
    Terbinafine Hydrochloride
    Cream 1%
    Antifungal Cream

    Full Prescription Strength

    NET WT 1 oz (30 g)

    63187-111-30
  • INGREDIENTS AND APPEARANCE
    TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-111(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:63187-111-151 in 1 CARTON12/01/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63187-111-301 in 1 CARTON12/01/2018
    230 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 - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079502574REPACK(63187-111) , RELABEL(63187-111)
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