Label: DEWZI ALCOHOL FREE HAND SANITIZER FRAGRANCE FREE- benzalkonium chloride liquid

  • NDC Code(s): 73126-031-01, 73126-031-02, 73126-031-03, 73126-031-04, view more
    73126-031-05, 73126-031-06, 73126-031-07
  • Packager: LAB-CLEAN, INC
  • 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 April 26, 2022

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  • Active ingredient

    Benzalkonium Chloride  0.1%

    Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

  • 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 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.

  • Directions

    • Spray a small amount of product into the palm of hand. Rub thoroughly over all surfaces of both hands.
    • Rub hands together briskly until dry.
  • Inactive ingredients

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

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    DEWZI ALCOHOL FREE HAND SANITIZER FRAGRANCE FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73126-031
    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:73126-031-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2021
    2NDC:73126-031-0288 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2021
    3NDC:73126-031-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2021
    4NDC:73126-031-04355 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2021
    5NDC:73126-031-05474 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2021
    6NDC:73126-031-06710 mL in 1 PACKAGE; Type 0: Not a Combination Product02/10/2021
    7NDC:73126-031-07946 mL in 1 PACKAGE; Type 0: Not a Combination Product02/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/10/202104/20/2024
    Labeler - LAB-CLEAN, INC (199822219)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAB-CLEAN, INC199822219manufacture(73126-031)
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