Label: ANTIBACTERIAL HAND WIPES- wipes cloth

  • 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 January 5, 2022

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Antimicroblal

  • USE

    ●Hand sanitizer to help reduce bacteria

    ●For use when soap and water are not available.

  • DO NOT USE

    ●in children less than 2 months old.

    ●on open skin wounds

  • WARNINGS

    For external use only.

  • WHEN USING

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

  • STOP USE

    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

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

  • INACTIVE INGREDIENT

    Purified water

    Glycerin

    Phenoxyethanol

    Propylene Glycol

    Aleo Barbadensis Extract

    Alpha-Tocopherol

    Fragrance

  • DIRECTIONS

    ●Apply to hands, allow to air dry without wiping.

    ●Children under 6 years of age should be supervised when using this product

  • THER INFORMATION

    ●Store in a cool, dry place, between 15°C-30°C(59°F-86°F)

    ●Avoid freezing and excessive heat above 40°C(104°F)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78691-100
    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
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78691-100-0175 in 1 PAIL01/05/2022
    13 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/05/2022
    Labeler - Quest USA Corp. (079869689)
    Establishment
    NameAddressID/FEIBusiness Operations
    Osike Cosmetics Co., Ltd.415803943manufacture(78691-100)