HAND SANITZER- ethyl alcohol gel 
Luxe Decor Sales Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Flammable. Keep away from flame and heat.

Stop use and ask a doctor if irritation develops

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

PDP

HAND SANITZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80511-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL740 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80511-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
2NDC:80511-001-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
3NDC:80511-001-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
4NDC:80511-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
5NDC:80511-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
6NDC:80511-001-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
7NDC:80511-001-073780 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/04/2020
Labeler - Luxe Decor Sales Ltd (204166933)
Registrant - Luxe Decor Sales Ltd (204166933)
Establishment
NameAddressID/FEIBusiness Operations
GUANGDONG INTENTLY BIOTECHNOLOGY CO., LTD.554531968manufacture(80511-001)

Revised: 1/2021
Document Id: b8b965a7-d88a-c03b-e053-2995a90aa128
Set id: ae7f2bac-bf1e-cf54-e053-2a95a90a7396
Version: 2
Effective Time: 20210112
 
Luxe Decor Sales Ltd