ALCOHOL HAND SANITIZER- alcohol solution 
Tri-State Media, 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 80% v/v

Purpose

Antiseptic

Uses

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 source of heat, fire, or flame.

Do not use in children less than 2 months of age. Do not use on open skin wounds.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if irritation or redness develops and lasts.

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

Directions

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.

Children under 6 years should be supervised when using this product.

Other information

Store at a temperature below 43C (110F).

May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Hydroxypropylcellulose (naturally derived), Glycerin, Isopropyl Myristate, Lauryl Lactate, Cetyl Lactate.

container labelAlcohol

Hand Sanitizer

with

Premium Skin Conditioners and Moisturizers

Contains

Ethyl Alcohol 80%

PRD# 99000736

Lot# 0040205

Expiry 04/2022

Net Contents: 4L

GenesisHealth

ALCOHOL HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75784-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
LAURYL LACTATE (UNII: G5SU0BFK7O)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETYL LACTATE (UNII: A7EVH2RK4O)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75784-001-044 L in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
2NDC:75784-001-011 L in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/23/2020
Labeler - Tri-State Media, LLC (005820446)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Chemical Canada251234027manufacture(75784-001)

Revised: 4/2020
Document Id: a446bae0-e240-5aa0-e053-2995a90a3419
Set id: a3fc0b3b-9250-35d2-e053-2a95a90afa96
Version: 2
Effective Time: 20200427
 
Tri-State Media, LLC