HAND SANITIZER- alcohol gel

hand sanitizer by

Drug Labeling and Warnings

hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Hygieia, 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 sanitizing

Warnings

For external use only

Flammable, keep away from fire & flames.

When using this product

• Avoid the eyes and mucous membranes.
• In case of contact, rinse area thoroughly with water
• Do not drink. If taken internally will produce serious gastric disturbances 

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately

Directions

Rub dime sized amount between hands until dry

Other information

• Store below 105 °F
• May discolor some fabrics

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol.

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80689-000
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80689-000-00	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/15/2020

Labeler - Hygieia (117628720)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(80689-000)