Label: AIRDEFENDER ALL DAY ANTIBACTERIAL SANITIZING SOLUTION REFILL PACK- benzalkonium chloride solution

  • NDC Code(s): 78976-003-15
  • Packager: Airdefender International Company Limited
  • 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 January 27, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.10%

  • Purpose

    Antiseptic

  • Use

    Help reduce bacteria contact that potentially can cause disease.

  • Warnings

    For external use only.

  • Do not use

    • on open skin wounds
  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, drink water. Seek medical help if condition gets worse.

  • Directions

    • Spray onto hands or skin and apply evenly until dry.
    • Remove large drops with clean towel within 15-20 seconds to avoid markings
  • Other information

    • Store in room temperature. Avoid direct sunlight.
    • Do not refrigerate.
    • Use within 9 months after opening
  • Inactive ingredients

    Titanium Dioxide, Purified Water

  • Questions or Comments?

    1-833-387-9949

  • Label

    label

  • INGREDIENTS AND APPEARANCE
    AIRDEFENDER ALL DAY ANTIBACTERIAL SANITIZING SOLUTION REFILL PACK 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78976-003
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78976-003-15150 mL in 1 POUCH; Type 0: Not a Combination Product01/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/27/2021
    Labeler - Airdefender International Company Limited (687086895)