Label: HAND WASH- benzalkonium 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 March 29, 2016

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • warnings

    For external use only: hands only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children

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

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, glycerin, lauramine oxide, cocamidopropyl betaine, PEG-150 distearate, coamide MEA, fragrance, citric acid, tetrasodiu EDTA, DMDM hydantoin, benzophenone-4, green 3, yellow 10

  • Adverse reactions

    DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344

    Contact us at 1-877-932-7948, or

    www.supervalu-ourownbrands.com

  • package label

    EQUALINE

    Antibacterial

    Foaming

    Hand Wash

    Pear Scent

    7.5 FL OZ (221 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-942
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-942-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:41163-942-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/07/2015
    Labeler - SUPERVALU INC. (006961411)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(41163-942)
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