GUSTAR HAND SANITIZER(ETHANOL)- alcohol gel

GUSTAR HAND SANITIZER(ETHANOL) by

Drug Labeling and Warnings

GUSTAR HAND SANITIZER(ETHANOL) by is a Otc medication manufactured, distributed, or labeled by GuStar Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ethanol

INACTIVE INGREDIENT

Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80

PURPOSE

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin
recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUSTAR HAND SANITIZER(ETHANOL) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73819-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73819-0001-1	25 mL in 1 POUCH; Type 0: Not a Combination Product	03/21/2020
2	NDC: 73819-0001-3	500 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/21/2020
3	NDC: 73819-0001-4	40 mL in 1 POUCH; Type 0: Not a Combination Product	03/21/2020
4	NDC: 73819-0001-2	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/21/2020

Labeler - GuStar Co Ltd (694234583)

Registrant - GuStar Co Ltd (694234583)

Establishment
Name	Address	ID/FEI	Business Operations
GuStar Co Ltd		694234583	manufacture(73819-0001) , label(73819-0001)