Label: COMPOUND W- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 4, 2017

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  • SPL UNCLASSIFIED SECTION

    Compound W®
    Salicylic Acid Wart Remover

    MAXIMUM STRENGTH
    FAST ACTING GEL

    NET WT 0.25 OZ (7 g)

    Drug Facts

  • Active ingredient

    Salicylic acid 17% w/w

  • Purpose

    Wart remover

  • Use

    • for the removal of common and plantar warts.
    • the common wart is easily recognized by the rough "cauliflower-like" appearance on the surface.
    • the plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.
  • Warnings

    For external use only.

    Flammable. Keep away from fire and flame.

    Do not use

    • on irritated skin or on any area that is infected or reddened.
    • on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.
    • if you have diabetes or poor blood circulation.

    When using this product

    • avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.
    • avoid inhaling vapors
    • cap tightly and store at room temperature away from heat

    Stop use and ask a doctor if

    discomfort persists.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • wash affected area
    • may soak wart in warm water for 5 minutes
    • dry area thoroughly
    • by squeezing tube gently, apply one drop at a time to sufficiently cover each wart
    • let dry
    • repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
  • Inactive ingredients

    alcohol, camphor, castor oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropanol, nitrocellulose, polysorbate 80

  • Questions?

    1-800-443-4908 CompoundW.com

    ©2016 Distributed by Medtech Products Inc.
    Tarrytown, NY 10591
    A Prestige Brands Company
    Made in Brazil

  • PRINCIPAL DISPLAY PANEL - 7 gm Tube Box Label

    CommUnityCare Federally Qualified Health Centers

    COMPOUND
    W GEL 7 GM

    Date:

    Name:
    Dr.

    APPLY 1 DROP TO CLEAN, DRY WART 1-2 TIMES DAILY.
    REPEAT UP TO 12 WEEKS.

    1-1-11

    123456

    Compound W GEL 7gm NDC 76413-348-07

    Batch: 123456
    Lot: 123456
    Exp: 1-1-11
    MEDTECH

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 7 gm Tube Box Label
  • INGREDIENTS AND APPEARANCE
    COMPOUND W 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-348(NDC:63029-595)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.17 g  in 7 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
    HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-348-071 in 1 BOX11/30/2017
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358B03/15/2014
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-348) , RELABEL(76413-348)
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