Label: SOMXL- salicylic acid solution

  • NDC Code(s): 70463-000-01
  • Packager: WR Group Skin Care Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredient

    Salicylic acid 17% (w/w)

    Purpose

    Wart remover

  • Use

    For the removal of common warts. The common wart is easily recognized by the rough

    "cauliflower-like" appearace on the surface.

  • Warnings

    For external use only

    If product gets into eyes, flush with water for 15-minutes. Avoid inhaling vapors.

    Do not use

    • on irritated skin
    • on any area that is infected or reddened
    • if you are diabetic or if you have poor blood circulation
    • piles
    • birthmarks
    • warts with hair growing from them
    • on moles
    • warts on the face or mucous membreanes

    Stop use and ask a doctor if

    discomfort persists

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wash affected area (May soak wart in warm water for 15-minutes if desired).
    • Dry area throughly.
    • Apply small amount with applicator to cover each wart. Let dry.
    • Repeat this procedure once ot twice daily as needed for up to 12-weeks.
  • Inactive ingredients

    castor oil, ethyl lactate, flexible collodion, polybutene, (Contains alcohol 18% v/v and ether 53% v/v from flexible collodion.)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SOMXL 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70463-000
    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
    CASTOR OIL (UNII: D5340Y2I9G)  
    ETHYL LACTATE (UNII: F3P750VW8I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70463-000-011 in 1 BOX06/26/2023
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02806/26/2023
    Labeler - WR Group Skin Care Ltd (592719822)
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