Label: AIRE-MASTER FOAMING AB TRICLOSAN FREE- benzalkonium chloride liquid

  • NDC Code(s): 65133-190-01, 65133-190-02, 65133-190-03, 65133-190-04, view more
    65133-190-05, 65133-190-06, 65133-190-07, 65133-190-08, 65133-190-09, 65133-190-10, 65133-190-11, 65133-190-12, 65133-190-13, 65133-190-14, 65133-190-15, 65133-190-16
  • 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 January 29, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride  0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    -For hand washing 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 eye

    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.

  • DOSAGE & ADMINISTRATION

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

    -Rub thoroughly over all surfaces of both hands for 15 seconds.

    -Rinse with potable water.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine

    oxide, citric acid

  • QUESTIONS

    Questions or comments?

    1-888-667-6066

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    AIRE-MASTER  FOAMING AB TRICLOSAN FREE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65133-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65133-190-094 in 1 PACKAGE01/01/2016
    1NDC:65133-190-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:65133-190-02208198 mL in 1 DRUM; Type 0: Not a Combination Product01/01/2016
    3NDC:65133-190-03946353 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2016
    4NDC:65133-190-1024 in 1 PACKAGE01/01/2016
    4NDC:65133-190-04236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:65133-190-126 in 1 PACKAGE01/01/2016
    5NDC:65133-190-1112 in 1 PACKAGE
    5NDC:65133-190-05532.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:65133-190-138 in 1 PACKAGE01/01/2016
    6NDC:65133-190-061000 mL in 1 POUCH; Type 0: Not a Combination Product
    7NDC:65133-190-1548 in 1 PACKAGE01/01/2016
    7NDC:65133-190-1424 in 1 PACKAGE
    7NDC:65133-190-0750.2 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:65133-190-164 in 1 PACKAGE01/01/2016
    8NDC:65133-190-081000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Aire-Master of America, Inc. (057897381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aire-Master of America, Inc.057897381manufacture(65133-190)