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 20, 2022

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.12%

  • Purpose

    Antimicroblal

  • Use

    ●Hand sanitizer to help reduce bacteria
    ●For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    ●on children less than 2 months old.
    ●on open skin wounds

  • WHEN USING

    When using this product do not get in eyes. If

    contact is made rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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.

  • Directions

    ●Apply to hands, allow to air dry without wiping.
    ●Children under 6 years of age should be supervised when using this product

  • Other information

    ●Store in a cool,dry place.
    ●Avoid freezing and excessive heat.

  • Inactive ingredients

    Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

  • Package Label - Principal Display Panel

    1600

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79866-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79866-002-011600 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Osike Cosmetics Co., Ltd. (415803943)
    Establishment
    NameAddressID/FEIBusiness Operations
    Osike Cosmetics Co., Ltd.415803943manufacture(79866-002)
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