Label: AIRDEFENDER DAILY ANTIBACTERIAL SANITIZING MIST- benzalkonium chloride spray

  • 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 30, 2022

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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

  • Package Label - Principal Display Panel

    DISTRIBUTED BY: Airdefender USA

    airDefender Daily Antibacterial Sanitizing Mist (20 mL) NDC: 78976-001-20

    20ml

    airDefender Daily Antibacterial Sanitizing Mist (100 mL) NDC: 78976-001-10

    100ml

    airDefender Daily Antibacterial Sanitizing Mist - OUTER CONTAINER

    BOX

  • INGREDIENTS AND APPEARANCE
    AIRDEFENDER DAILY ANTIBACTERIAL SANITIZING MIST 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78976-001
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78976-001-201 in 1 BOX06/19/2020
    120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:78976-001-101 in 1 BOX06/19/2020
    2100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:78976-001-501 in 1 BOX06/19/202011/30/2022
    3500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/19/2020
    Labeler - Airdefender International Company Limited (687086895)
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