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

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 February 12, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride  0.13%

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  • PURPOSE

    Purpose

    Antimicrobial

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  • INDICATIONS & USAGE

    Uses

    -For hand washing to decrease bacteria on the skin

    -Recommended for repeated use

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  • 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.

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  • 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.

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  • 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.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine

    oxide, citric acid

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  • QUESTIONS

    Questions or comments?

    1-888-667-6066

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  • INGREDIENTS AND APPEARANCE
    AIRE-MASTER  FOAMING AB TRICLOSAN FREE
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65133-190
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE .13 g  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65133-190-09 4 in 1 PACKAGE
    1 NDC:65133-190-01 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:65133-190-02 208198 mL in 1 DRUM; Type 0: Not a Combination Product
    3 NDC:65133-190-03 946353 mL in 1 CONTAINER; Type 0: Not a Combination Product
    4 NDC:65133-190-10 24 in 1 PACKAGE
    4 NDC:65133-190-04 236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:65133-190-12 6 in 1 PACKAGE
    5 NDC:65133-190-11 12 in 1 PACKAGE
    5 NDC:65133-190-05 532.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:65133-190-13 8 in 1 PACKAGE
    6 NDC:65133-190-06 1000 mL in 1 POUCH; Type 0: Not a Combination Product
    7 NDC:65133-190-15 48 in 1 PACKAGE
    7 NDC:65133-190-14 24 in 1 PACKAGE
    7 NDC:65133-190-07 50.2 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:65133-190-16 4 in 1 PACKAGE
    8 NDC:65133-190-08 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2016
    Labeler - Aire-Master of America, Inc. (057897381)
    Establishment
    Name Address ID/FEI Business Operations
    Aire-Master of America, Inc. 057897381 manufacture(65133-190)
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