HAND SANITIZER GEL- ethyl alcohol gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Bajaj Medical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away.

Directions

• Place enough product in your palm to thoroughly cover hands and rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

water (aqua), carbomer, propanediol 2-amino methyl-1 propanol solution

Package/Label Principal Display Panel

HAND SANITIZER GEL

ORIGINAL

MADE IN THE USA

128 fl oz (3785 mL)

FOR EXTERNAL USE ONLY

NDC: 6103-446-07

Drug Facts

Bajaj Medical Chicago, IL 60609 www.bajajmedical.com

1-855-680-0101 Product Made In U.S.A.

Store below 110°F (43°C) May discolor certain fabrics or surfaces

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61037-446
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61037-446-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/16/2020
2	NDC: 61037-446-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/16/2020
3	NDC: 61037-446-05	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/16/2020
4	NDC: 61037-446-06	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/16/2020
5	NDC: 61037-446-07	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/16/2020
6	NDC: 61037-446-08	1893 mL in 1 JUG; Type 0: Not a Combination Product	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/16/2020

Labeler - Bajaj Medical, LLC (078774921)

Registrant - Bajaj Medical, LLC (078774921)

Establishment
Name	Address	ID/FEI	Business Operations
Bajaj Medical, LLC		078774921	label(61037-446) , analysis(61037-446) , manufacture(61037-446) , pack(61037-446) , repack(61037-446) , relabel(61037-446)