PROTECT U GUARD ANTIBACTERIAL FOAMING- benzalkonium chloride liquid 
Protect U Guard, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

18 Ounce Label1000 ML Front1000 ML Back

PROTECT U GUARD ANTIBACTERIAL FOAMING 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-346
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-346-204 in 1 CARTON11/06/2017
1NDC:71788-346-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2NDC:71788-346-606 in 1 CARTON11/06/2017
2NDC:71788-346-50530 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/06/2017
Labeler - Protect U Guard, LLC (080070945)
Establishment
NameAddressID/FEIBusiness Operations
Aire-Master of America, Inc057897381manufacture(71788-346)
Establishment
NameAddressID/FEIBusiness Operations
Protect U Guard, LLC080070945relabel(71788-346)

Revised: 3/2020
Document Id: a19c3fa7-3dab-2e58-e053-2995a90a8c8f
Set id: 5d46f12d-d095-44ac-e053-2a91aa0a0386
Version: 3
Effective Time: 20200324
 
Protect U Guard, LLC