PROTECT U GUARD ANTIBACTERIAL FOAMING- benzalkonium chloride liquid

Protect U Guard Antibacterial Foaming by

Drug Labeling and Warnings

Protect U Guard Antibacterial Foaming by is a Otc medication manufactured, distributed, or labeled by Protect U Guard, LLC, Aire-Master of America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For Hand washing to decrease bacteria on the skin

Recommended for repeated use

Warnings

For External use only.

When using this product avoid contact with eyes. In case of eye 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. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product avoid contact with eyes. In case of eye 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.

Inactive ingredients

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid

Questions or comments?

1-813-815-0530 or www.protectuguard.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECT U GUARD ANTIBACTERIAL FOAMING 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71788-346
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 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71788-346-20	4 in 1 CARTON	11/06/2017
1	NDC: 71788-346-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2	NDC: 71788-346-60	6 in 1 CARTON	11/06/2017
2	NDC: 71788-346-50	530 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	11/06/2017

Labeler - Protect U Guard, LLC (080070945)

Establishment
Name	Address	ID/FEI	Business Operations
Aire-Master of America, Inc		057897381	manufacture(71788-346)

Establishment
Name	Address	ID/FEI	Business Operations
Protect U Guard, LLC		080070945	relabel(71788-346)