FARMACY ANTISEPTIC HAND SANITIZER- 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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ACTIVE INGREDIENT

Active ingredients: ETHANOL 70% v/v

INACTIVE INGREDIENT

Inactive ingredients

Water, Glycerin, Carbomer, Dipropylene Glycol, Isopropylene Myristate, Triethanolamine, Citrus Paradisi (Grapefruit) Seed Extract, Aloe Barbadensis Leaf Juice Powder

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings

For external use only. Flammable. Keep away from heat and flame
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When using this product
keep out of eyes, ears, and mouth.
if contact occurs, rinse eyes thoroughly with water
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Stop use and ask a doctor
if irritation or rash occurs.

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

Uses

Hand sanitizer to help reduce bacteria on skin only when water and soap is not available

Directions

Directions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of container

FARMACY ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73819-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Dipropylene Glycol (UNII: E107L85C40)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Trolamine (UNII: 9O3K93S3TK)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73819-0005-160 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - GuStar Co Ltd (694234583)
Registrant - GuStar Co Ltd (694234583)
Establishment
NameAddressID/FEIBusiness Operations
GuStar Co Ltd694234583manufacture(73819-0005)

Revised: 4/2020
Document Id: 1b3c5414-38a6-40b7-877b-b73faa32da1f
Set id: 7524e203-e162-42b1-8f6b-0c3a2268a31b
Version: 1
Effective Time: 20200418
 
GuStar Co Ltd