Label: EQUATE- 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 November 29, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Inactive Ingredients

    Inactive Ingredients: Water (Agua), Cetrimonium Chloride, Glycerine, Tetrasodium EDTA, Fragrance, Dimehicone, Disodium Cocoamphodiacetate, Aloe Barbadensis Leaf Extract, Citric Acid.

  • Purpose

    Antiseptic

  • Uses AND Directions

    Use hand sanitizer to help reduce bacteria on skin.

    Directions

    Wet hands thoroughly with product and rub into skin until dry.  Children under 6 ears of age should be supervised by an adult when using.

  • Warnings

    For external use only.

    Flammable Keep away from heat and flame.  Do not store 104o ​F/40​o ​C

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

  • When using

    When using this product avoid contact with eyes.  If contact occurs, rinse thoroughly with water.

  • Stop use

    Stop use and ask doctor if irritation or redness develops.

  • Directions

    Wet hands thoroughly with product and rub into skin until dry.  Children under 6 years of age should be supervised by an adult when using.

  • PRINCIPAL DISPLAY PANEL – Bottle Label

    equate Beauty                NDC 49035-591-01

    Foaming Hand Sanitizer

    Aloe

    2 FL oz. (59mL)

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

    DISTRIBUTED BY: Wal-Mart Stores, Inc.

    Bentonville, AR 72716

    PRODUCT OF CHINA

    EQUATE BEAUTY PDP LABEL

  • INGREDIENTS AND APPEARANCE
    EQUATE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-591
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-591-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/21/2017
    Labeler - Walmart (051957769)
    Registrant - Apotex Inc. (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc.209429182label(49035-591)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(49035-591)
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