Label: FOAMFRESH ALCO-FREE HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 11429-1001-0, 11429-1001-2, 11429-1001-3, 11429-1001-4, view more
    11429-1001-7, 11429-1001-8, 11429-1001-9
  • Packager: Woodbine Products Company
  • 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 June 17, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses:

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings:

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Pump a small amount of foam into palm of hand.

    Rub thoroughly over all surfaces of both hands.

    Rub hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    FoamFresh

    Alco-Free Hand Sanitizer

    Formulated to reduce the number of germs on the hands that can cause infection and illness

    Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere

    Use on clean, non-soiled hands any time when rinsing with water is not available

    Kills 99.99% of common germs that can cause disease

    PK

    Woodbine Products Company

    915 West Smith Road

    Medina, Ohio 44256

    wwww.woodbineproducts.com

    Made in the U.S.A.

    Stock # 4350         1000 ml (34 fl. oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    FOAMFRESH ALCO-FREE HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1001-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    2NDC:11429-1001-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    3NDC:11429-1001-41500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    4NDC:11429-1001-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    5NDC:11429-1001-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    6NDC:11429-1001-91100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2014
    7NDC:11429-1001-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2014
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1001)
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