Label: ANTISEPTIC HAND WIPE- alcohol, benzalkonium chloride 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 August 27, 2020

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  • DOSAGE & ADMINISTRATION

    Remove and unfold wipe from package

    Wipe hands and nails thoroughly

    Allow sking to dry without wiping

    Discard Properly

    Single Use Only

  • ACTIVE INGREDIENT

    Ethyl Alcohol 15%

    Benzalkonium Chloride .1%

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    Antiseptic

  • INTENDED USE OF THE DEVICE

    Hand sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    Flammable

    Keep away from fire or flame

    For external use only

    When using this product aboid use near eyes

    If contact occurs, rinse thoroughly with water

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Remove and unfold wipe from package

    Wipe hands and nails thoroughly

    Allow skin to dry without wiping

    Discard properly

    Single Use Only

  • Other

    Store at room temperature

  • INACTIVE INGREDIENT

    Propylene glycol

    Phenoxyethanol

    Cetylpyridinium Chloride

    Water

    spunlace non-woven fabric

  • PRINCIPAL DISPLAY PANEL

    Front LabelBack LabelBack Label Continued

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND WIPE 
    alcohol, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90024-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90024-001-016.5 g in 1 PACKAGE; Type 0: Not a Combination Product08/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/27/2020
    Labeler - Metro Medical Equipment Mfg. Inc (161891197)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Yiukin Paper Products Co.,ltd526049172manufacture(90024-001)
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