CVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]

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CVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]
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NDC 59779-523-01
Set ID 17684ba2-3c2c-4259-84fa-3833f19e5a4d
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
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 jock itch (tinea cruris)
    • relieves itching, burning, cracking and scaling which accompany this condition
  • 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 jock itch 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 68°-77° F (20°-25°C)
    • 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: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    CVS
    pharmacy    ™

    NDC 59779-523-01

    Compare to the active
    ingredient in Lamisil AT®*

    JOCK ITCH
    CREAM
    TERBINAFINE HYDROCHLORIDE
    CREAM 1% - ANTIFUNGAL

    • Cures most jock itch
    • Relieves itching & burning
    • Full prescription strength

    Actual Product Size on Back Panel

    NET WT 0.5 OZ (15 g)

    Principal Display Panel - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CVS 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-523
    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:59779-523-011 in 1 CARTON
    115 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 - CVS Pharmacy (062312574)
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