HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GOOSE CREEK CANDLES, LLC, Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 70%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

Do not eat or drink. Topical application only. Flammable. Keep away from fire or flame. For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor

Stop use and ask doctor if irritation or rash persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Put enough product in your palm to cover hands & rub together until dry. Children under 6 years of age should be supervised when using this product.

Other information

Store below 110 F (43C).

May discolor certain fabric surfaces

Inactive ingredient

Water/Aqua, Glycerin, Fragrance, Polysorbate 20, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice

Package Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82463-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73.409 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.495 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	22.52 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.49 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.98 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82463-078-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/16/2022

Labeler - GOOSE CREEK CANDLES, LLC (080086461)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(82463-078)