Label: ACS FOAMING ANTIBACTERIAL HANDSOAP- benzalkonium chloride soap

  • NDC Code(s): 75044-271-10, 75044-271-20
  • Packager: American Chemical Systems II, LLC
  • 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 11, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient 

    Benzalkonium chloride .13%

  • Purpose

    Antibacterial

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    For external use only : hands only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds
    When using this product
    • do not get into eyes. In case of contact, rinse eyes thoroughly with water
    Stop use and ask a doctor if

    • irritation or redness develop
    • 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 thoroughly
    •  apply a small amount and work into a lather.
    •  rinse well and dry completely
    •  supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    aloe vera (Aloe barbadensis) leaf juice, betaine, fragrance, glycerin, propanediol, tocopheryl acetate, water

  • Questions?

    +1-800-889-3489

    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    READ PRECAUTIONS CAREFULLY
    Safety Data Sheet (SDS) is available at:
    americanchemicalsystemsii.com

    Foaming Antibacterial Hand Soap is a gentle, effective hand soap specially formulated to keep skin healthy and clean. It will help decrease bacteria on the skin and has a pleasant spring fragrance.

    WARNING Harmful if Swallowed

    As always, American Chemical Systems is working harder to make your cleaning decisions easier.

    Manufactured by:
    AMERICAN CHEMICAL SYSTEMS II, LLC
    3505 W. 29th Street South,
    Wichita, Kansas 67217

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ACS FOAMING ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75044-271
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BETAINE (UNII: 3SCV180C9W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75044-271-103.8 L in 1 BOTTLE; Type 0: Not a Combination Product08/08/202012/20/2023
    2NDC:75044-271-201 L in 1 BOTTLE; Type 0: Not a Combination Product08/08/202012/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/08/202012/20/2023
    Labeler - American Chemical Systems II, LLC (016631058)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Chemical Systems II, LLC016631058manufacture(75044-271)