Label: HAND SANIT1ZING 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 May 17, 2021

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride

  • PURPOSE

    Antiseptic

  • Use

    Use for hand sanitizing to reduce bacteria on the skin.

  • WARNINGS

    For external use only.When using this product

  • STOP USE

    lf irritation appears, stop use.

  • DO NOT USE

    Keep out of eyes.In case of contact, rinse eyes with water.

  • ASK DOCTOR

    Consult a doctor if irritation persists more than 72 hours.
    lf swallowed,get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children, except with adult supervision.

  • Directions

    Thoroughly wipe hands and face as desired.
    Allow to dry without wiping.
    Discard wipe in trash receptacle after use.Do not flush.

  • INACTIVE INGREDIENT

    Water(Aqua),Polyhexamethylene biguanide hydrochloride,Benzalkonium Chloride,Didecyldimethylammoniumchloride,Cetylpyridinium Chloride,monohydrate,Ethylhexylglycerin,Aloe Barbadensis Leaf Extract,Glycerine.

  • STORAGE AND HANDLING

    Store at room temperature

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANIT1ZING WIPES 
    wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81925-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81925-001-0150 in 1 PACKAGE05/18/2021
    10.1 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2021
    Labeler - Zhejiang Healyou Hygienics Technology Co., Ltd. (723726954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Healyou Hygienics Technology Co., Ltd.723726954manufacture(81925-001)
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