AIRE-MASTER FOAMING AB HANDSOAP- triclosan liquid

Aire-Master by

Drug Labeling and Warnings

Aire-Master by is a Otc medication manufactured, distributed, or labeled by Aire-Master of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AIRE-MASTER  FOAMING AB HANDSOAP
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65133-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65133-170-09	4 in 1 CASE	01/01/2016
1	NDC: 65133-170-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 65133-170-02	208198 mL in 1 DRUM; Type 0: Not a Combination Product	01/01/2016
3	NDC: 65133-170-03	946353 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2016
4	NDC: 65133-170-10	24 in 1 CASE	01/01/2016
4	NDC: 65133-170-04	237 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 65133-170-11	12 in 1 CASE	01/01/2016
5	NDC: 65133-170-05	532 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 65133-170-12	8 in 1 PACKAGE	01/01/2016
6	NDC: 65133-170-06	1000 mL in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 65133-170-13	48 in 1 CASE	01/01/2016
7	NDC: 65133-170-07	50 mL in 1 BOTTLE; 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	part333E	01/01/2016

Labeler - Aire-Master of America, Inc. (057897381)

Establishment
Name	Address	ID/FEI	Business Operations
Aire-Master of America, Inc.		057897381	manufacture(65133-170)