75% ETHYL ALCOHOL GEL SANITIZER- alcohol liquid 
Medisys USA, Inc.

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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75% Ethyl Alcohol Gel

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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.

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

Water, Acrylates Copolymer, Fragrance, Aminoethyl Propanol

Package Label - Principal Display Panel

59 mL NDC: 78364-500-02 59ml label

236.5 mL NDC: 78364-500-08 237 ml label

75% ETHYL ALCOHOL GEL SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78364-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.14 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78364-500-08236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/02/2020
2NDC:78364-500-0259.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/02/2020
Labeler - Medisys USA, Inc. (106534427)

Revised: 9/2020
Document Id: b02a0d3b-f39d-18a1-e053-2a95a90aa6ab
Set id: a63e19c0-a0a5-e896-e053-2a95a90a7ccd
Version: 5
Effective Time: 20200925
 
Medisys USA, Inc.