Label: COMPOUND W- salicylic acid gel

  • NDC Code(s): 63029-595-12, 63029-595-14, 63029-595-25
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2022

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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

    Compound W
    WART REMOVER
    MAXIMUM STRENGTH
    FAST ACTING GEL
    Salicylic acid
    NET WT 0.25 OZ (7g)

    PRINCIPAL DISPLAY PANEL Compound W WART REMOVER MAXIMUM STRENGTH FAST ACTING GEL Salicylic acid NET WT 0.25 OZ (7g)

  • PRINCIPAL DISPLAY PANEL

    Compound W
    WART REMOVER SYSTEM
    MAXIMUM STRENGTH
    FAST ACTING GEL + CONSEAL
    Salicylic acid
    NET WT 0.25 OZ (7g)

    PRINCIPAL DISPLAY PANEL Compound W WART REMOVER SYSTEM MAXIMUM STRENGTH FAST ACTING GEL + CONSEAL Salicylic acid NET WT 0.25 OZ (7g)

  • PRINCIPAL DISPLAY PANEL

    Compound W
    Total Care Wart & Skin
    Salicylic acid – Wart Remover
    GEL NET WT 0.25 OZ (7g)

    Compound W Total Care Wart & Skin Salicylic acid – Wart Remover GEL NET WT 0.25 OZ (7g)

  • INGREDIENTS AND APPEARANCE
    COMPOUND W 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-595
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID170 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (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:63029-595-251 in 1 CARTON03/15/2014
    17 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63029-595-121 in 1 CARTON03/15/2014
    27 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    3NDC:63029-595-141 in 1 CARTON03/15/2014
    37 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B03/15/2014
    Labeler - Medtech Products Inc. (122715688)
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