Label: COLOR ELEMENT ANTIBACTERIAL WIPES- benzalkonium chloride cloth

  • NDC Code(s): 74934-043-01
  • Packager: Zhejiang iColor Biotech Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin
  • 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

    • wet hands thoroughly with product and allow to dry.
    • Discard wipes in trash receptacle after use. Do not flush.
    • Children under 6 years of age should be supervised by adult when applying this product.
  • Inactive ingredients

    Water, Propylene Glycol, Didecyldimonium Cholride, Polyaminopropyl Biguanide, Aloe Barbadensis Leaf Water, phenoxyethanol, Edetate Disodium Anhydrous, Citric Acid, Sodium citrate, Dimethicone

  • Questions or Comments?

    212-551-2657

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    COLOR ELEMENT ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74934-043
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74934-043-0170 in 1 CANISTER08/05/202001/31/2026
    13.64 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/05/202001/31/2026
    Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)