FOAM HAND SANITIZER- ethyl alcohol liquid

Foam Hand Sanitizer by

Drug Labeling and Warnings

Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Luxe Decore Sales Ltd., Guangzhou (Biotechnology) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 74% v/v

Purpose

Ethyl Alcohol 74% v/v................Antiseptic

Uses

highly effective alcohol-based hand sanitizing foam which sanitizes the skin without the need for water.

Warnings

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep away from children. If swallowed, call a Poison Control Centre or a doctor. Supervise children using this product.

WARNINGS

Flammable. Keep away from flame and heat.

STOP USE

Stop use and ask a doctor if irritation develops

WARNINGS

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

Directions ■ adults and children 2 years and older: apply to hands and rub for at least 30 seconds till dry

Other Information

Store below 40°C (100°F).

Inactive Ingredients

water, PEG-10 dimethicone, glycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAM HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80511-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	1480 mL  in 2000 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80511-002-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2021
2	NDC: 80511-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2021
3	NDC: 80511-002-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2021
4	NDC: 80511-002-04	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/29/2021

Labeler - Luxe Decore Sales Ltd. (204166933)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou (Biotechnology) Co., Ltd.		554531968	manufacture(80511-002)