ETHYL ALCOHOL- ethyl alcohol gel 
Marine Essence Biosciences Corporation of USA

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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Ethyl Alcohol Hand Sanitizer

Ethanol alcohol 80% v/v ……………………………………..………………………………………………………………………...Antiseptic

Hand sanitizer to help reduce bacteria that potentially can cause disease.

glycerin, hydrogen peroxide, carbomer 940, triethanolamine, purified water USP

Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL

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

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

In children less than 2 months of age

On open skin wounds

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.

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Gel form

Warnings for external use only-hands

To help reduce bacteria on the hands that can potentially cause disease.

ME Bio Ethyl Alcohol

ETHYL ALCOHOL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73764-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73764-002-01500 mL in 1 BOTTLE, PUMP; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/23/2020
2NDC:73764-002-02236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
3NDC:73764-002-03177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
4NDC:73764-002-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
5NDC:73764-002-05250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/23/2020
Labeler - Marine Essence Biosciences Corporation of USA (116587566)
Establishment
NameAddressID/FEIBusiness Operations
Marine Essence Biosciences Corporation of USA116587566manufacture(73764-002) , pack(73764-002) , label(73764-002)

Revised: 6/2020
Document Id: a736596e-6da4-37a1-e053-2995a90ac312
Set id: a1ba4cc4-969e-1c96-e053-2995a90ad2ff
Version: 3
Effective Time: 20200603
 
Marine Essence Biosciences Corporation of USA