Label: NEW LIFE ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid

  • NDC Code(s): 49681-015-10, 49681-015-18
  • Packager: New Life Products, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 February 2, 2023

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    • Hand soap to decrease bacteria on skin. • Recommended for repeated use.

  • Warnings:

    For external use only.

    Flammable. Keep away from fire or flame.

    When using this product avoid contact with face, eyes, and broken skin. If eye contact occurs, flush thoroughly with water and seek medical advice.

    Stop use and ask doctor if irritation and redness develops.

    KEEP OUT OF REACH OF CHILDREN.

  • Directions

    • Apply to hands and wet as needed. Lather vigorously for at least 15 second. Wash skin, rinse thoroughly and dry

    • Children under 6 years of age should be supervised by an adult when using this product.

  • Inactive Ingredients:

    Water (Aqua), Lauramidopropylamine Oxide, Lauramine Oxide, Cocamidopropyl Betaine, Glycerin, Cetrimonium Chloride, Citric Acid, Tetrasodium EDTA, PEG-150 Distearate, Sodium Chloride, Sodium Benzoate, Phenoxyethanol, Fragrance (Parfum), Orange 4 (CI 15510), Yellow 6 (CI 15985).

  • SPL UNCLASSIFIED SECTION

    Kills Germs +

    Gently Cleanses & Moisturizes

    ORIGINAL

    AFAM CONCEPT, Inc. • Chicago, IL 60629

    Watford WD24 7GN, UK • 800-262-2326

    www.newlifesanitizer.com

    cruelty free

    MADE IN USA

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    NEW LIFE ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-015-10295 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    2NDC:49681-015-18532 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/16/2020
    Labeler - New Life Products, Inc. (117815140)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Life Products, Inc.117815140manufacture(49681-015)
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