Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Use as hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store below 110*F (43*C) may dis color certain fabrics/surfaces

Inactive ingredients

glycerin, purified water USP, hydroxyethylcellulose

Package Label - Principal Display Panel

3780 mL NDC: 79730-003-01 3780 ml label

18930 mL NDC: 79730-003-05 18930 ml label

208197648 mL NDC: 79730-003-55 20819764 ml label

124918530 mL NDC: 79730-003-33 124918530 ml label

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79730-003(NDC:74100-003)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	76.578357 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.8782 mL in 100 mL
WATER (UNII: 059QF0KO0R)	22.0800871 mL in 100 mL
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)	0.46039 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.00289 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79730-003-01	3780 mL in 1 JUG; Type 0: Not a Combination Product	07/13/2020
2	NDC:79730-003-05	18930 mL in 1 JUG; Type 0: Not a Combination Product	07/13/2020
3	NDC:79730-003-55	208197648 mL in 1 DRUM; Type 0: Not a Combination Product	07/13/2020
4	NDC:79730-003-33	1249185300 mL in 1 TANK; Type 0: Not a Combination Product	07/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/13/2020

Labeler - Gemini Industries Inc. (927112891)

Name	Address	ID/FEI	Business Operations
Establishment
Gemini Industries Inc.		927112891	repack(79730-003)