Otc - Active Ingredient
Ethanol alcohol 80% v/v ……………………………………..………………………………………………………………………...Antiseptic
Ethyl Alcohol
FDA Label NDC 73764-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marine Essence Biosciences Corporation Of Usa for the product Ethyl Alcohol (NDC 73764-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, inactive ingredient, dosage & administration, otc - when using, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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.
Otc - Do Not Use
In children less than 2 months of age
On open skin wounds
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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.
* Please review the disclaimer below.
