Label: VERRUGUIN- salicylic acid gel

  • 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 May 6, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Salicylic Acid 17%

  • PURPOSE

    Uses: For the removal of common warts. The common wart is easily recognized by the rough "cauliflower-like" appearance of the surface.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Verruguin

    Removedor de Verrugas

    Wart Remover

    Salicylic Acid 17%

  • DOSAGE & ADMINISTRATION

    Directions Adults: Wash affected area and dry thoroughly. Apply small amount at a time with brush to sufficiently cover each wart. Let dry. Repeat this procedure once or twice daily as needed for up to 2 weeks.

  • WARNINGS

    WARNING: For external use only. Do not use; in or near eyes or mucous membranes, on irritated skin, if prone to allergic reaction to any ingredient in this product, on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes, on any area that is infected or reddened, on large areas of the body, on wounds or damaged skin, if you are diabetic, or if you have poor blood circulation. Ask a doctor or pharmacist before use if you are; taking any other medication, or Drinking alcohol. Stop use and ask a doctor if; irritation occurs, condition worsens or does not improve or discomfort persist. If pregnant or breast-feeding. Ask a health professional before use.

    Keep the bottle tightly closed

  • INACTIVE INGREDIENT

    Inactive Ingredients: flexible collodion, ethyl alcohol.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    VERRUGUIN 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10095-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PYROXYLIN (UNII: KYR8BR2X6O)  
    ETHER (UNII: 0F5N573A2Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10095-008-0115 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B05/05/2015
    Labeler - World Perfumes, Inc (101312044)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfumes, Inc101312044manufacture(10095-008)