NDC 78376-235 Evaxo 70% Ethyl Rubbing Alcohol

Ethyl Alcohol

NDC Product Code 78376-235

NDC 78376-235-16

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Evaxo 70% Ethyl Rubbing Alcohol with NDC 78376-235 is a a human over the counter drug product labeled by Evaxo International Inc. The generic name of Evaxo 70% Ethyl Rubbing Alcohol is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Evaxo International Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Evaxo 70% Ethyl Rubbing Alcohol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 70 mL/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ACETONE (UNII: 1364PS73AF)
  • METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of 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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Evaxo International Inc
Labeler Code: 78376
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Evaxo 70% Ethyl Rubbing Alcohol Product Label Images

Evaxo 70% Ethyl Rubbing Alcohol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Ethyl alcohol (70% by volume)

Purpose

First aid antiseptic

Warnings

For external use only.Flammable, Keep away from fire or flame.Ask a doctor before use if you have deep wounds, animal bites, or serious burnsWhen using this product*do not get into eyes.*do not apply over large areas of the body.*do not use longer than one week.Stop use and ask a doctor if condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. in case of ingestion, get medical help or contact a poison control center right away.

Directions

*Clean affected area.*Apply small amount of this product on the area 1-3 times daily.*if bandaged, let dry first.*may be covered with a sterile bandage.

Other Information

*Store at room temperature*will produce serious gastric disturbances if taken internally.

* Please review the disclaimer below.