Label: SANITIZING HAND- benzalkonium chloride soap

  • 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 November 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredient

    Benzalkonium Chloride, 0.13%

  • Purpose

    Antimicrobial Agent

  • Use

    for cleansing hands and decreasing bacteria on the skin.

  • Warnings

    - For external use only.

    - Do not use if you are allergic to any of the ingredients.

    - When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.

    - Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.

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

  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Polysorbate 20, Sucrose Cocoate, Glycerin, Polyquaternium-7, Hydroxyethylcellulose, Phenoxyethanol, Ethylhexylglycerin, Tetrasodium EDTA, Fragrance (Naturally Derived), Aloe Vera Barbadensis Leaf Juice1, Chamomilla Recutita (Matricaria) Flower Extract1, Camelia Sinensis Leaf Extract1, Vitis Vinifera (Grapeseed) Extract1, Helianthus Annuus (Sunflower) Seed Oil1

    1
    Organic Ingredient
  • Directions For Use

    - Press dispensing pump to release product into hands, add water and rub thoroughly around both sides of hands and between fingers. Rinse off and towel dry.

    - For adults and children 2 years and over.

    - For children under 2 years of age, consult a doctor before use.

  • PRINCIPAL DISPLAY PANEL - 370 ml Bottle Label

    PURIGEN™

    Sanitizing
    Hand Soap

    • Kills 99.9% of Germs
    • Safe for Sensitive Skin
    • Foaming Hand Wash

    Paraben Free
    No Artificial Fragrance
    Made with Organic Ingredients

    12.5 fl oz (370 ml)

    PRINCIPAL DISPLAY PANEL - 370 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    SANITIZING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80994-004
    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)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sucrose Cocoate (UNII: 3H18P0UK73)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Chamomile (UNII: FGL3685T2X)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80994-004-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:80994-004-02370 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Not Finalpart333A05/01/2020
    Labeler - BELLA BRANDS INC (034908755)
    Establishment
    NameAddressID/FEIBusiness Operations
    BELLA BRANDS INC034908755MANUFACTURE(80994-004)
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