GUSTAR HAND SANITIZER (ETHANOL)- alcohol gel 
GuStar 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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Drug Facts

ACTIVE INGREDIENT

Ethyl alcohol 62%

INACTIVE INGREDIENTS

Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80

PURPOSE

Antiseptic

WARNINGS

■ For external use only.
■ Flammable. ■ Keep away from heat and Flame.

When using this product
■ Keep out of eyes, ears and mouth.
■ If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor
■ If irritation and rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Uses

Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.

Directions

■ Wet hands thoroughly with product and rub hands together until dry.
■ Supervise children under 6 years of age when using.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of pouch

GUSTAR HAND SANITIZER (ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73819-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73819-0002-125 mL in 1 POUCH; Type 0: Not a Combination Product03/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/21/2020
Labeler - GuStar Co Ltd (694234583)
Registrant - GuStar Co Ltd (694234583)
Establishment
NameAddressID/FEIBusiness Operations
DASOL CO.,LTD.557839013manufacture(73819-0002)

Revised: 5/2020
Document Id: 497c6c8b-8c67-4430-9f93-31882b7b0466
Set id: a198033e-fa74-35eb-e053-2a95a90a0e13
Version: 2
Effective Time: 20200525
 
GuStar Co Ltd