Ethyl Alcohol by Marine Essence Biosciences Corporation of USA ETHYL ALCOHOL gel

Ethyl Alcohol by

Drug Labeling and Warnings

Ethyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Marine Essence Biosciences Corporation of USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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

WHEN USING

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.

DO NOT USE

In children less than 2 months of age

On open skin wounds

STOP USE

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

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

INSTRUCTIONS FOR USE

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 SAFETY INFORMATION

Other Information

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

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

DOSAGE FORMS & STRENGTHS

Gel form

WARNINGS

Warnings for external use only-hands

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETHYL ALCOHOL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73764-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73764-002-01	500 mL in 1 BOTTLE, PUMP; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	03/23/2020
2	NDC: 73764-002-02	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/23/2020
3	NDC: 73764-002-03	177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/23/2020
4	NDC: 73764-002-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2020

Labeler - Marine Essence Biosciences Corporation of USA (116587566)

Establishment
Name	Address	ID/FEI	Business Operations
Marine Essence Biosciences Corporation of USA		116587566	manufacture(73764-002) , pack(73764-002) , label(73764-002)