Label: ANTHEM HAND SANITIZING WIPES- 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 February 12, 2021

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  • Drug Facts

  • Active Ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic

  • Uses

    • For hand sanitizing to decrease bacteria on the kin.
    • Apply topically to the skin to help prevent cross contamination.
    • Recommended for repeated use.
    • Dries in seconds
  • Warnings

    • For external use only
    • May irritate eyes

    Keep Out Of Reach Of Children

    • Use Under Adult Supervision
  • Directions For Use

    • Pull back and remove wipe. Reseal label.
    • Apply to hands.
    • Allow to dry without wiping.
  • Inactive Ingredients

    Aloe barbadensis leaf juice, Citric acid, decyl glucoside, ethylhexylglycerin, fragrance, glycerin, isopropyl alcohol, phenoxyethanol, polysorbate 20, potassium sorbate, purified water, sodium benzoate, tocopheryl acetate

  • Questions or Comments?

    Anthem LLC, 60 Page Rd Clifton NJ 07012

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    ANTHEM HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71505-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71505-004-8080 in 1 PACKAGE06/02/2020
    13.09 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/02/2020
    Labeler - Disposable Hygiene LLC dba Anthem (079848737)
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