PROTECT U GUARD ALCOHOL HAND SANITIZER- ethyl alcohol hand sanitizer gel PROTECT U GUARD 62% FOAMING HAND SANITIZER- ethyl alcohol liquid

Protect U Guard 63% Foaming Hand Sanitizer Fresh by

Drug Labeling and Warnings

Protect U Guard 63% Foaming Hand Sanitizer Fresh by is a Otc medication manufactured, distributed, or labeled by Protect U Guard, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethanol 62%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin

Recommended for repeated use

Warnings

For External Use Only.

Flammable, keep away from fire or flame.

When using this product do not use in or near eyes. In case of eye contact, flush thoroughly with water.

Stop use and ask docotr if irritation and redness develop and 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.

Keep out of reach of children.

Stop Use and Ask Doctor

if irritation and redness develop and persists for more than 72 hours.

Directions

Dispense an adequate amount in your palm to cover all surfaces of hands completely

Rub hands together until dry

Supervise children in the use of this product

Other Information

Do not store above 100 o F (38 o C)

May discolor some fabrics

Inactive Ingredients

Water, DEA-C8-18 Perfluoroalkylethyl Phosphate, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Citric Acid

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECT U GUARD ALCOHOL HAND SANITIZER 
ethyl alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71788-678
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 980 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71788-678-60	48 in 1 CARTON	03/19/2020
1	NDC: 71788-678-50	81 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	03/19/2020

PROTECT U GUARD 62% FOAMING HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71788-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71788-123-20	4 in 1 CARTON	11/06/2017
1	NDC: 71788-123-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2	NDC: 71788-123-60	12 in 1 CARTON	11/06/2017
2	NDC: 71788-123-50	530 mL in 1 BOTTLE, PUMP; 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	11/06/2017

Labeler - Protect U Guard, LLC (080070945)

Establishment
Name	Address	ID/FEI	Business Operations
Aire-Master of America		057897381	manufacture(71788-678, 71788-123)

Establishment
Name	Address	ID/FEI	Business Operations
Protect U Guard, LLC		080070945	repack(71788-123, 71788-678)