Label: ANTISEPTIC- benzethonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 8, 2022

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  • Active Ingredient

    Benzethonium chloride 0.1%

  • Purpose

    Antiseptic

  • Uses

    • To clean superficial wounds
    • For washing small superfical wounds
    • Aids in removal of foreign material such as dirt and debris
    • First-aid product
  • Warnings

    For external use only.

    This product is not for use on wild or domestic animal bites. If you have an animal bite, consult your physician immediately.

    Do not use this product for more than 10 days. If condition worsens or persists, see your physician.

    Do not bandage tightly.

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

    Keep out of reach of children

  • Directions

    Apply to affected area.

    Adults and children 2 years of age or older: Spray on the affected area up to 3 times per day.

    May be covered with a sterile bandage, if bandaged let dry first.

    Children under 2 years: Consult a physician prior to use.

  • Other information

    Store at room temperature

  • Inactive ingredients

    Deionized water, disodium EDTA, glycerin, methylparaben, polyethylene-polypropylene glycol, sodium hydroxide

  • Package Label

    MP00032 Antiseptic Skin and Wound Cleanser Artwork

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66977-032-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/1997
    Labeler - MPM Medical, LLC (081241522)
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