BIO HAND SANITIZER GE L- ethanol spray

BIO HAND SANITIZER GE L by

Drug Labeling and Warnings

BIO HAND SANITIZER GE L by is a Otc medication manufactured, distributed, or labeled by Seoul Food Research & Development Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 75 % v/v

INACTIVE INGREDIENTS

Glycerin, Hydroxy Propyl Methyl Cellulose, Water

PURPOSE

Antimicrobial

WARNINGS

For external use only
Flammable. Keep away from heat and flame.

When using this product ■ Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.

Stop use and ask a doctor if skin irritation or rash develops.

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

KEEP OUT OF REACH OF CHILDREN

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

Uses

■ Hand sanitizer to help reduce bacteria on the skin that could cause disease
■ Recommended for repeated use

Directions

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.
■ Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

■ Store between 15-30℃(59-86℉)
■ Avoid freezing and excessive heat above 40℃(104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO HAND SANITIZER GE L 
ethanol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80642-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80642-020-01	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2020

Labeler - Seoul Food Research & Development Co., Ltd. (688787758)

Registrant - Seoul Food Research & Development Co., Ltd. (688787758)

Establishment
Name	Address	ID/FEI	Business Operations
Seoul Food Research & Development Co., Ltd.		688787758	manufacture(80642-020)