Label: ANTIBACTERIAL BODY WASH- benzalkonium chloride lotion

  • 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 July 27, 2020

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  • Active ingredients

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    to decrease bacteria on the skin

  • Warnings

    For external use only

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Keep out of reach of children

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

  • Directions

    • work a small amount into a lather
    • scrub thoroughly
    • rinse
  • Inactive ingredients

    water, PEG-120 methyl glucose dioleate, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, fragrance, sodium sulfate, myristamidopropylamine oxide, sodioum chloride, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • principal display panel

    Antibacterial Body Wash

    21 FL OZ (621 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BODY WASH 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.313 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    cetrimonium chloride (UNII: UC9PE95IBP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-337-56621 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/15/2014
    Labeler - Vi-Jon (150931459)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-337)
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