Label: ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride solution

  • 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 June 1, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • 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

    Wet hands thoroughly with product and allow to dry without wiping

  • Other Information

    • store at room temperature
  • Inactive ingredients

    Water, dodecylbetaine, lauramine oxide

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77624-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77624-000-0060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2020
    Labeler - DaLian Jaesve Cleaning Product Co., Ltd (527127803)
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Safety

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Related Resources

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