Label: AIRE-MASTER ANTIBACTERIAL LIQUID HANDSOAP- triclosan liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    65133-180-01, 65133-180-02, 65133-180-03, 65133-180-04, view more
    65133-180-05, 65133-180-06, 65133-180-07, 65133-180-08, 65133-180-09, 65133-180-10, 65133-180-11, 65133-180-12, 65133-180-14, 65133-180-15, 65133-180-16, 65133-180-17, 65133-180-18, 65133-180-19, 65133-180-20, 65133-180-21, 65133-180-22, 65133-180-23, 65133-180-24, 65133-180-25, 65133-180-26, 65133-180-27, 65133-180-28
  • 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

    Triclosan .3%

  • Purpose

    Purpose

    Antiseptic

  • Indications

    Indications:

    Handwash to help reduce bacteria that potentially can cause disease.

  • Directions

    Directions: Wet hands, apply leberal amount of product and rub hands

    together for 30 seconds. Rinse thoroughly.

  • Warnings

    Warnings:

    -FOR EXTERNAL USE ONLY

    -Keep away from eyes. In case of eye contact, flush thoroughly with water

    and then seek medical advice.

    -If swallowed, drink large amounts of water and seek medical attention.

    -Avoid contact with face and broken skin. If contact occurs, flush with

    water.

    -If irritation develops, discontinue use. If condition persists, consult a

    doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STORAGE AND HANDLING

    Note:  Keep from freezing.

  • Other Ingredients

    Other Ingredients:

    Water, Sodium Lauryl Sulfate, Cocamide DEA, Cocamidopropyl Betaine,

    Glycerin, DMDM Hydantoin, Fragrance, Aloe Barbadensis Leaf Juice,

    Sodium Chloride, Citric Acid.

  • Questions or Comments

    Questions or Comments?  888-667-6066

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    AIRE-MASTER  ANTIBACTERIAL LIQUID HANDSOAP
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65133-180
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65133-180-144 in 1 CASE01/01/2016
    1NDC:65133-180-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:65133-180-28708 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    3NDC:65133-180-1524 in 1 CASE01/01/2016
    3NDC:65133-180-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:65133-180-03208198 mL in 1 DRUM; Type 0: Not a Combination Product01/01/2016
    5NDC:65133-180-1624 in 1 CASE01/01/2016
    5NDC:65133-180-04251 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:65133-180-176 in 1 CASE01/01/2016
    6NDC:65133-180-04251 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:65133-180-1824 in 1 CASE01/01/2016
    7NDC:65133-180-05251 mL in 1 CONTAINER; Type 0: Not a Combination Product
    8NDC:65133-180-198 in 1 CASE01/01/2016
    8NDC:65133-180-061000 mL in 1 POUCH; Type 0: Not a Combination Product
    9NDC:65133-180-2024 in 1 CASE01/01/2016
    9NDC:65133-180-0759 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:65133-180-21180 in 1 CASE01/01/2016
    10NDC:65133-180-0759 mL in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:65133-180-224 in 1 CASE01/01/2016
    11NDC:65133-180-081893 mL in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:65133-180-2348 in 1 CASE01/01/2016
    12NDC:65133-180-0981 mL in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:65133-180-10946353 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2016
    14NDC:65133-180-2412 in 1 CASE01/01/2016
    14NDC:65133-180-1163974 mL in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:65133-180-2512 in 1 CASE01/01/2016
    15NDC:65133-180-1163974 mL in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:65133-180-266 in 1 CASE01/01/2016
    16NDC:65133-180-1163974 mL in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:65133-180-27100 in 1 CASE01/01/2016
    17NDC:65133-180-1237 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(65133-180)