GNA- alcohol gel 
GREENSYS OF NORTH AMERICA LLC

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

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

Acrylate copolymer, glycerin, hydrogen peroxide,Triethanolamine , water. 

Package Label - Principal Display Panel

:Label

GNA 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76692-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76692-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
2NDC:76692-001-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
3NDC:76692-001-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
4NDC:76692-001-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
5NDC:76692-001-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
6NDC:76692-001-06208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
7NDC:76692-001-071040990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
8NDC:76692-001-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - GREENSYS OF NORTH AMERICA LLC (075577393)
Establishment
NameAddressID/FEIBusiness Operations
GREENSYS OF NORTH AMERICA LLC075577393manufacture(76692-001)

Revised: 6/2020
Document Id: 58509677-5688-406c-a41c-65ec8a0f47ae
Set id: 84b28ece-12bf-495c-87de-b6eac4ab1123
Version: 1
Effective Time: 20200609
 
GREENSYS OF NORTH AMERICA LLC