AIRE-MASTER ALCOHOL FREE FOAMING SANITIZER- benzalkonium chloride aerosol, foam

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 Ingredients

Active Ingredients

Benzalkonium Chloride 0.1%

Purpose

Purpose

Antimicrobial

Uses

Uses

-For hand sanitizing to decrease bacteria on the skin

-Recommended for repeated use

Warnings

Warnings

For external use only

When using this product avoid contact with eyes. In case of 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.

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.

Directions

Directions  -Pump a small amount of foam into palm of hand

-Rub thoroughly over all surfaces of both hands  -Rub hands together

briskly until dry

Inactive ingredients

Inactive ingredients   Water, Cetrimonium Chloride, Laurtrimonium

Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

Questions or comments?

Questions or comments? 1-888-977-3726

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AIRE-MASTER  ALCOHOL FREE FOAMING SANITIZER
benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65133-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65133-200-09	4 in 1 CASE	02/01/2016
1	NDC: 65133-200-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 65133-200-08	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	02/01/2016
3	NDC: 65133-200-02	208198 mL in 1 DRUM; Type 0: Not a Combination Product	02/01/2016
4	NDC: 65133-200-03	946353 mL in 1 CONTAINER; Type 0: Not a Combination Product	02/01/2016
5	NDC: 65133-200-10	24 in 1 CASE	02/01/2016
5	NDC: 65133-200-04	236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 65133-200-11	12 in 1 CASE	02/01/2016
6	NDC: 65133-200-05	532 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 65133-200-17	6 in 1 CASE	02/01/2016
7	NDC: 65133-200-05	532 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 65133-200-14	4 in 1 CASE	02/01/2016
8	NDC: 65133-200-12	8 in 1 CASE
8	NDC: 65133-200-06	1000 mL in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 65133-200-16	48 in 1 CASE	02/01/2016
9	NDC: 65133-200-15	24 in 1 CASE
9	NDC: 65133-200-07	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	part333A	02/01/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Aire-Master of America, Inc.		057897381	manufacture(65133-200)