BIO HAND SANITIZER GE L- ethanol spray 
Seoul Food Research & Development Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of bottle

BIO HAND SANITIZER GE L 
ethanol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80642-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80642-020-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - Seoul Food Research & Development Co., Ltd. (688787758)
Registrant - Seoul Food Research & Development Co., Ltd. (688787758)
Establishment
NameAddressID/FEIBusiness Operations
Seoul Food Research & Development Co., Ltd.688787758manufacture(80642-020)

Revised: 10/2020
Document Id: 02099691-891c-4c65-a98b-d1cae14a5d03
Set id: bb8eb255-76e6-462a-81b9-7eabaa63ef0a
Version: 1
Effective Time: 20201023
 
Seoul Food Research & Development Co., Ltd.