Label: AIRE-MASTER ALCOHOL FREE FOAMING SANITIZER- benzalkonium chloride aerosol, foam

  • NDC Code(s): 65133-200-01, 65133-200-02, 65133-200-03, 65133-200-04, view more
    65133-200-05, 65133-200-06, 65133-200-07, 65133-200-08, 65133-200-09, 65133-200-10, 65133-200-11, 65133-200-12, 65133-200-14, 65133-200-15, 65133-200-16, 65133-200-17
  • Packager: Aire-Master of America, Inc.
  • 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 July 27, 2022

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  • Active Ingredients

    Active Ingredients

    Benzalkonium Chloride 0.1%

  • Purpose

    Purpose

    Antimicrobial

  • Uses

    Uses

    -For hand sanitizing to decrease bacteria on the skin

    -Recommended for repeated use

  • Warnings

    Warnings

    For external use only

    When using this product avoid contact with eyes. In case of contact,

    flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition

    persists for more than 72 hours.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a

    Poison Control Center right away.

  • Directions

    Directions  -Pump a small amount of foam into palm of hand

    -Rub thoroughly over all surfaces of both hands  -Rub hands together

    briskly until dry

  • Inactive ingredients

    Inactive ingredients   Water, Cetrimonium Chloride, Laurtrimonium

    Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

  • Questions or comments?

    Questions or comments? 1-888-977-3726

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    AIRE-MASTER  ALCOHOL FREE FOAMING SANITIZER
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65133-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65133-200-094 in 1 CASE02/01/201607/20/2022
    1NDC:65133-200-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:65133-200-081000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product02/01/201603/31/2023
    3NDC:65133-200-02208198 mL in 1 DRUM; Type 0: Not a Combination Product02/01/201607/20/2022
    4NDC:65133-200-03946353 mL in 1 CONTAINER; Type 0: Not a Combination Product02/01/201607/20/2022
    5NDC:65133-200-1024 in 1 CASE02/01/201607/20/2022
    5NDC:65133-200-04236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:65133-200-1112 in 1 CASE02/01/201607/20/2022
    6NDC:65133-200-05532 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:65133-200-176 in 1 CASE02/01/201607/20/2022
    7NDC:65133-200-05532 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:65133-200-144 in 1 CASE02/01/201607/20/2022
    8NDC:65133-200-128 in 1 CASE
    8NDC:65133-200-061000 mL in 1 POUCH; Type 0: Not a Combination Product
    9NDC:65133-200-1648 in 1 CASE02/01/201607/20/2022
    9NDC:65133-200-1524 in 1 CASE
    9NDC:65133-200-0750 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/201608/31/2024
    Labeler - Aire-Master of America, Inc. (057897381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aire-Master of America, Inc.057897381manufacture(65133-200)
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