HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Andaz Group LLC, Bath Concept Cosmetics (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 75%

Purpose

Antiseptic

Use

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

Warnings

For external use only.

Flammable, keep away from fire and flame.

When using this product

• Do not get into eyes.
• If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop.

Keep out of reach of children. 

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

Directions

wet hands thoroughly with product and allow to dry without wiping.

Other information

• Store below 105 °F
• May discolor some fabrics.

Inactive ingredients

Water, Carbomer, Aminomethyl Propanol.

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79631-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79631-000-00	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/18/2020

Labeler - Andaz Group LLC (022059440)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(79631-000)