AIRE-MASTER ANTIBACTERIAL LIQUID 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

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

INGREDIENTS AND APPEARANCE

AIRE-MASTER  ANTIBACTERIAL LIQUID HANDSOAP
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65133-180
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65133-180-14	4 in 1 CASE	01/01/2016
1	NDC: 65133-180-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 65133-180-28	708 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016
3	NDC: 65133-180-15	24 in 1 CASE	01/01/2016
3	NDC: 65133-180-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 65133-180-03	208198 mL in 1 DRUM; Type 0: Not a Combination Product	01/01/2016
5	NDC: 65133-180-16	24 in 1 CASE	01/01/2016
5	NDC: 65133-180-04	251 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 65133-180-17	6 in 1 CASE	01/01/2016
6	NDC: 65133-180-04	251 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 65133-180-18	24 in 1 CASE	01/01/2016
7	NDC: 65133-180-05	251 mL in 1 CONTAINER; Type 0: Not a Combination Product
8	NDC: 65133-180-19	8 in 1 CASE	01/01/2016
8	NDC: 65133-180-06	1000 mL in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 65133-180-20	24 in 1 CASE	01/01/2016
9	NDC: 65133-180-07	59 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 65133-180-21	180 in 1 CASE	01/01/2016
10	NDC: 65133-180-07	59 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 65133-180-22	4 in 1 CASE	01/01/2016
11	NDC: 65133-180-08	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 65133-180-23	48 in 1 CASE	01/01/2016
12	NDC: 65133-180-09	81 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 65133-180-10	946353 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2016
14	NDC: 65133-180-24	12 in 1 CASE	01/01/2016
14	NDC: 65133-180-11	63974 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 65133-180-25	12 in 1 CASE	01/01/2016
15	NDC: 65133-180-11	63974 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 65133-180-26	6 in 1 CASE	01/01/2016
16	NDC: 65133-180-11	63974 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 65133-180-27	100 in 1 CASE	01/01/2016
17	NDC: 65133-180-12	37 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(65133-180)