HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ko-pack Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

Flammable, keep away from fire or flame

For external use only.

WHEN USING

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.

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

STOP USE

Stop use and ask a doctor if irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

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

Directions

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

Other information

• Store at a temperature below 110 F (43 C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Glycerin, Hydrogen Peroxide, Hydroxypropylcellulose, Water

Package Label - Principal Display Panel

59 mL NDC: 78948-648-02

473 mL NDC: 78948-648-16

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78948-648
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78948-648-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2020
2	NDC: 78948-648-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/02/2020

Labeler - Ko-pack Inc (122354374)