Label: COLOR ELEMENT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 74934-048-01, 74934-048-02
  • Packager: Zhejiang iColor Biotech Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose:

    Antiseptic

  • Uses

    For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.

  • Warnings

    For external use only

    When using this product

    do not use in or near eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears on the skin.

    Keep out of reach of children.

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

  • Directions

    ●Place enough product on hands to cover all surfaces. Rub hands together until dry.
    ●Children under 6 years of age should be supervised by adult when applying this product.
    ●Do not use on children less than 2 months of age or on open skin wounds.

  • Inactive ingredients

    Water, Propylene Glycol, Polyquaternium-37,Didecyldimonium Chloride,Polyaminopropyl Biguanide, Aloe Barbadensis Leaf Water, Fragrance, Phenoxyethanol.

  • Package Labeling:30ml

    Box4

  • Package Labeling:2ml

    Bottle

  • INGREDIENTS AND APPEARANCE
    COLOR ELEMENT ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74934-048
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74934-048-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202001/31/2026
    2NDC:74934-048-022 mL in 1 BAG; Type 0: Not a Combination Product09/07/202001/31/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/07/202001/31/2026
    Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)
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