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, Whisk Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Skin Antimicrobial

Use

Reduces amount of bacteria on hands

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 of 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.

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.

Directions

Apply a palmful to hands and forearms.

Scrub thoroughly for at least fifteen seconds

Rinse completely and dry.

Inactive Ingredients

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance

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: 71788-001
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
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71788-001-60	12 in 1 CARTON	06/03/2020
1	NDC: 71788-001-50	530 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71788-001-20	4 in 1 CARTON	06/03/2020
2	NDC: 71788-001-10	1000 mL in 1 BOTTLE, DISPENSING; 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	06/03/2020

Labeler - Protect U Guard, LLC (080070945)

Establishment
Name	Address	ID/FEI	Business Operations
Protect U Guard, LLC		080070945	relabel(71788-001)

Establishment
Name	Address	ID/FEI	Business Operations
Whisk Products Inc		834270639	manufacture(71788-001)