Label: FOAMFRESH E-2 SANITIZER CLEANSER- benzalkonium chloride liquid

  • NDC Code(s): 11429-1002-0, 11429-1002-3, 11429-1002-6, 11429-1002-7, view more
    11429-1002-8, 11429-1002-9
  • 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 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses:

    For hand washing 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 with water.

    Stop use and ask a doctor if irritation or redness develops, or if 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Pump a small amount of foam into palm of hand.

    Rub thoroughly over all surfaces of both hands for 15 seconds.

    Rinse with potable water.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid.

  • PRINCIPAL DISPLAY PANEL

    FoamFresh

    E-2 Sanitizer Cleanser

    For Food Service and Health Care

    For Food Service:

    A "one-step" E-2 hand wash to effectively reduce bacteria flora on the skin without need for a prewash.

    Contains no perfume, dyes or contaminants to affect food products.

    For Health Care:

    Mild yet effective hand wash for high risk areas.

    Dye and fragrance free formula for frequent hand washings.

    Excellent skin compatibility.

    Woodbine Products Company

    915 West Smith Road

    Medina, OH 44256

    www.woodbineproducts.com

    Made in USA

    Stock # 4560                 1000 ml (34 fl. oz.)

    FoamFresh E-2 Sanitizer

    With Moisturizers

    container label

  • INGREDIENTS AND APPEARANCE
    FOAMFRESH E-2 SANITIZER CLEANSER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1002
    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)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1002-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    2NDC:11429-1002-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    3NDC:11429-1002-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    4NDC:11429-1002-63785 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2014
    5NDC:11429-1002-91100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2014
    6NDC:11429-1002-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/26/2014
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1002)
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