Label: LIFECARE ANTIBACTERIAL HAND 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 November 24, 2020

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  • Product facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antimicrobial

  • Use

    • personal hand hygiene
  • Warnings

    For external use only.

    Do not use

    • in the eyes.

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • Tear the package and use
  • Other Information

    • Store between 59-86°F (15-30°C) 
    • Avoid freezing and excessive heat above 104°F (40°C)
  • Inactive ingredients

    WATER, GLYCERIN, PHENOXYETHANOL, POLYAMINOPROPYL BIGUANIDE, POLYSORBATE 20, COCO NUCIFERA OIL.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    LIFECARE ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80044-011
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80044-011-011 in 1 PATCH11/16/2020
    15 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 finalpart333E11/16/2020
    Labeler - Danthan Military NJ Inc. (117589050)
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