Label: FAMILY WELLNESS LIQUID WART REMOVER- salicylic acid liquid

  • 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 June 25, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients

    Salicylic acid  17% w/w

  • PURPOSE

    Purpose

    Wart remover

  • INDICATIONS & USAGE

    Uses  •for the removal of common and plantar warts. The common

    wart is easily recognized by the 'cauliflower-like' appearance of

    the surface. Plantar wart is recognized by its location only on the bottom

    of the foot, its tenderness and the interruption of the foot pattern.

  • WARNINGS

    Warnings  For external use only.

    Flammable •keep away from fire or flame

    cap bottle tightly and store at room temperature away from heat

    Do not use

    •if you are diabetic or have poor blood circulation, except under

    the advice and supervision of a doctor or a podiatrist

    •on genital warts and warts on the face

    •on moles, birthmarks and warts with hair growing from them

    •on mucuous membranes  •on irritated, infected or reddend skin

    When using this product

    •avoid contact with eyes. If product gets into the eye, flush with

    water for 15 minutes  •avoid inhaling vapors

    Stop use and ask a doctor if discomfort persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children  If swallowed, get medical help or

    contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions  •wash affected area, may soak wart in warm

    water for 5 minutes  •dry area thoroughly  •apply small

    amount of wart remover with applicator to sufficiently cover each

    wart  •let dry and repeat this procedure once or twice daily as

    needed until wart is removed for up to 12 weeks

  • STORAGE AND HANDLING

    Other information  store between 20° - 30° C (68° - 86° F)

  • INACTIVE INGREDIENT

    Inactive ingredients camphor, castor oil, ethanol, ethyl

    acetate, nitrocellulose

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  LIQUID WART REMOVER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-600-011 in 1 CARTON06/25/2017
    19 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B06/25/2017
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-600)