Label: HAND SANITIZER- hand sanitizer foam bac aerosol, foam

  • 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 December 5, 2022

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  • Ideal Foam Hand Sanitizer

    Product Description: Non-Flammable, Non-Toxic Hand Sanitizer for everyday use. Will not dry hands. Reduces Common Harmful Germs and Bacteria. FDA approved formulation, manufactured in an FDA Registered Facility. For use when soap and water is not always available.

    NDC: 75056-0008-01

    Produced for WALBRO by:

    Atlanta Supersource, Inc.

    3655 Kennesaw 75 Parkway:

    Suite 100

    Kennesaw, Georgia 30144

    EMERGENCY RESPONSE PROVIDED BY: Chemtrec 1.800.424.9300

    Item Number: CLE224

  • Active Ingredient (s)

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available. Recommended for repeated use.

  • Warnings

    For external use only.

  • When using this product

    keep our to eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask doctor

    If irritation or rash occurs.

  • Keep out of reach of children

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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Inactive Ingredients

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide

    Glycereth-17, Citric Acid Monohydrate - these are not on the Product Data Sheet and Katie explained they do not nee to be listed.

  • Questions or Comments?

    Call us at 833.423.0006

  • Ideal Hand Sanitizer Foam

    Net Contents 1 Gallon (3.78L)

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer foam bac aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75056-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 99.8703 g  in 100 g
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) 0.0099 g  in 100 g
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.0099 g  in 100 g
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) 0.0099 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75056-008-013785 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/11/2020
    Labeler - Atlanta Supersource, Inc., (806786778)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlanta Supersource, Inc.,806786778manufacture(75056-008)
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