Label: BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER liquid

  • 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 March 4, 2022

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  • Active Ingredients

    Benzalkotlm Chloide 0.13% v/v

  • ​Purpose

    Antiseptic

  • ​Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    - In children less than 2 months of age

    - On open skin wounds

  • when using this product

    keep out of eyas, ears, and mouth, In case of contact with eyes . rinse eyes thoroughly with water.

  • stop use and ask a doctor if

    irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing

  • Other Information

    Store between 15-30℃ ( 59-86℉)

    Avcid freezing and excessive heat above 40℃ ( 104℉)

  • Inactive Ingredients

    aloe , glycerin , sterile distilled watet

  • Package Label - Principal Display Panel

    74046-006-0174046-006-0274046-006-0374046-006-0474046-006-0574046-006-0674046-006-0774046-006-0874046-006-0974046-006-10

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER 
    benzalkonium chloride instant hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74046-006
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74046-006-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    2NDC:74046-006-0215 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    3NDC:74046-006-0320 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    4NDC:74046-006-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    5NDC:74046-006-0540 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    6NDC:74046-006-0650 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    7NDC:74046-006-0760 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    8NDC:74046-006-08100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    9NDC:74046-006-09250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    10NDC:74046-006-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/15/2022
    Labeler - Dongguan Mingyi Medical Products Co., Ltd. (554526907)
    Registrant - Dongguan Mingyi Medical Products Co., Ltd. (554526907)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongguan Mingyi Medical Products Co., Ltd.554526907manufacture(74046-006)
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