Label: ASSURE- benzethonium chloride liquid

  • 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 May 20, 2020

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  • Active ingredient

    Benzethonium chloride 0.2% w/v

  • Purpose

    Antimicrobial

  • Use

    • For hand washing to decrease bacterial on skin.
    • Recommended for repeated use.
  • Warning

    For external use only.

  • When using this product

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if irritation or redness develops, or if conditions persist.

  • Keep out of reach of children

    Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center.

  • Directions

    • Hands need not be washed prior to using.
    • For one step handwash/antibacterial skin cleaning.
    • Place product in palm of hand, add water, work up a lather.
    • Rinse hands thoroughly with potable water after washing.
  • Inactive ingredients


    C9-11 Pareth-6; Caprylyl/Capryl Oligpglucoside; Citric acid; DMDM Hydantoin; Dye; Fragrance; Glycerine; Poly(Laurylglucoside)-7; Water.

  • Questions or comments?

    320-693-2477

  • Principal Display Panel

    Assure label

  • INGREDIENTS AND APPEARANCE
    ASSURE 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63131-1132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63131-1132-17570 in 1 CASE04/17/2007
    13785 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2007
    Labeler - Anderson Chemical Company (006179220)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anderson Chemical Company006179220manufacture(63131-1132)
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