Label: AIRE-MASTER FOAMING AB HANDSOAP- triclosan liquid

  • 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

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  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan .3%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses  Handwash to help reduce bacteria that potentially can cause disease

  • WARNINGS

    Warnings  For external use only

    Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention.

    Stop use and ask doctor if irritation and redness develop and 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  -Wet hands, apply liberal amount of product and rub hands together for 30 seconds.

    -Rinse thoroughly.

  • STORAGE AND HANDLING

    Other Information  -Keep from freezing.

  • INACTIVE INGREDIENT

    Inactive Ingredients  Water, TEA Lauryl Sulfate, Cocamidopropyl Betaine, Cocamide

    DEA, Glycerin, Fragrance, DMDM Hydantoin, Propylene Glycol, Aloe Barbadensis Leaf Juice.

  • QUESTIONS

    Questions or Comments? 800-525-0957  www.airemaster.com

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    AIRE-MASTER  FOAMING AB HANDSOAP
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65133-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65133-170-094 in 1 CASE01/01/2016
    1NDC:65133-170-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:65133-170-02208198 mL in 1 DRUM; Type 0: Not a Combination Product01/01/2016
    3NDC:65133-170-03946353 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2016
    4NDC:65133-170-1024 in 1 CASE01/01/2016
    4NDC:65133-170-04237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:65133-170-1112 in 1 CASE01/01/2016
    5NDC:65133-170-05532 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:65133-170-128 in 1 PACKAGE01/01/2016
    6NDC:65133-170-061000 mL in 1 POUCH; Type 0: Not a Combination Product
    7NDC:65133-170-1348 in 1 CASE01/01/2016
    7NDC:65133-170-0750 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 finalpart333E01/01/2016
    Labeler - Aire-Master of America, Inc. (057897381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aire-Master of America, Inc.057897381manufacture(65133-170)
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