Label: ANTIBACTERIAL HAND- 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 September 22, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    For washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes.
    • In case of eye contact, flush with water.

    Stop use and ask a doctor if

    • irritation and redness develop.

    + Keep out of reach of children.

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

    Wet hands with water, apply soap and rub for 20 seconds and rinse.

  • Inactive ingredients

    Water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, glycerin, polyquaternium -7, fragance, DMDM hydantoin, iodopropynyl butylcarbamate, butylene glycol, chamomilla recutita extract, aloe barbadensis extract, citral, limonene, citronellol, disodium EDTA, linalool, geraniol, hexyl cinnamal, citric acid, yellow 5 (CI 19140), red 40 (CI 16035), glycol distearate, cocamide MEA, Laureth-10

  • Questions?

    Email: info@aglamee.com

  • SPL UNCLASSIFIED SECTION

    Distributed by Cross-Border Manufacturers Inc.
    Dover, DE, 19901

  • PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label

    aglameé

    ANTIBACTERIAL
    hand
    soap

    FRESH CITRUS
    WITH CHAMOMILE +ALOE VERA

    ANTIBACTERIAL
    FORMULA

    500 ML | 16.9 FL.OZ

    PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78939-001
    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)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRAL (UNII: T7EU0O9VPP)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAURETH-10 (UNII: BD7AST04GA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78939-001-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A09/16/2020
    Labeler - CROSS BORDER MANUFACTURERS INC. (117543128)
    Establishment
    NameAddressID/FEIBusiness Operations
    Absara Cosmetics SAPI de CV816161236MANUFACTURE(78939-001)
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