HAND SANITZER- ethyl alcohol gel

Hand Sanitzer by

Drug Labeling and Warnings

Hand Sanitzer by is a Otc medication manufactured, distributed, or labeled by Luxe Decor Sales Ltd, GUANGDONG INTENTLY 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 gel 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, glycerin, carbomer, triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80511-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	740 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80511-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
2	NDC: 80511-001-03	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
3	NDC: 80511-001-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
4	NDC: 80511-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
5	NDC: 80511-001-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
6	NDC: 80511-001-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020
7	NDC: 80511-001-07	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/04/2020

Labeler - Luxe Decor Sales Ltd (204166933)

Registrant - Luxe Decor Sales Ltd (204166933)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGDONG INTENTLY BIOTECHNOLOGY CO., LTD.		554531968	manufacture(80511-001)