ANTIBACTERIAL HAND SANITIZER- alcohol gel
Gold Orient International Limited

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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Antibacterial Hand Sanitizer

for hand washing to decrease bacteria on the skin only when water is not available.

Drug Facts

Active Ingredients

Alcohol Denat. 80%

Purpose

Antiseptic

Place enough product in your plam to thoroughly cover your hands. Rub hands together briskly until dry.
Children under 6 years of age should be supervised when this product to avoid swallowing

Inactive Ingredients:

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomthyl Propanol

Warning

For External Use Only.
Flammable, keep away from heat or flame

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

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

In children less than 2 months of age.
On open skin wounds

Store at 68 to 77F (20-25C)
Do not store above 100F (43C)
You may report a serious advers reaction to Centric Beauty LLC, 350 5th Avenue, New York, NY 10118

label

ANTIBACTERIAL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51522-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51522-003-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/11/2020

Labeler - Gold Orient International Limited (679905914)

Name	Address	ID/FEI	Business Operations
Establishment
Gold Orient International Limited		679905914	manufacture(51522-003)

Antibacterial Hand Sanitizer

Drug Facts Active Ingredients

Purpose

Inactive Ingredients:

Warning

Drug Facts

Active Ingredients