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 70%

INACTIVE INGREDIENTS

Aloe Vera Gel, Grapefruit Seed Extract, Disodium EDTA, Butylene Glycol, Aminomethyl Propanol, Carbomer, Phenoxyethanol, Purified Water

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: GUSTAR HAND SANITIZER 40mL

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Package Label: GUSTAR HAND SANITIZER 100mL

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Package Label: GUSTAR HAND SANITIZER 500mL

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GUSTAR HAND SANITIZER (ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73819-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73819-0003-140 mL in 1 POUCH; Type 0: Not a Combination Product03/21/2020
2NDC:73819-0003-2100 mL in 1 TUBE; Type 0: Not a Combination Product03/21/2020
3NDC:73819-0003-3500 mL in 1 BOTTLE; 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
THE SUN CO.LTD694433104manufacture(73819-0003)

Revised: 5/2020
Document Id: 19b5386a-26fe-4d6a-ac78-f26ec39b3a16
Set id: a1982127-0fd6-973f-e053-2a95a90a3c1e
Version: 3
Effective Time: 20200526
 
GuStar Co Ltd