NDC 77457-004 Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol

Isopropyl Alcohol

NDC Product Code 77457-004

NDC CODE: 77457-004

Proprietary Name: Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Isopropyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 77457 - Unibeleza Industria E Comercio De Cosmeticos Ltda

NDC 77457-004-01

Package Description: 1 L in 1 BOTTLE, PLASTIC

NDC 77457-004-02

Package Description: 5 L in 1 BOTTLE, PLASTIC

NDC Product Information

Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol with NDC 77457-004 is a a human over the counter drug product labeled by Unibeleza Industria E Comercio De Cosmeticos Ltda. The generic name of Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Unibeleza Industria E Comercio De Cosmeticos Ltda

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.

Biotipo Pharma Medical Bioclear 70% Isopropyl 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.

  • ISOPROPYL ALCOHOL 700 mL/L

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • WATER (UNII: 059QF0KO0R)

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: Unibeleza Industria E Comercio De Cosmeticos Ltda
Labeler Code: 77457
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: 07-09-2020 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.

Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol Product Label Images

Biotipo Pharma Medical Bioclear 70% Isopropyl 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

Isopropyl alcohol 70% v/v

Purpose

First aid antiseptic

Uses

  • Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol first aid to help prevent the risk of infection in:
  • Minor cutsscrapesburns

Warnings

For external use only.

Flammable

Keep away from fire or flame, heat, spark electrical

Ask A Doctor Before Use

For deep or puncutre wounds, animal bites or serious burns

When Using This Product

  • Do not get into eyesdo not apply over large areas of the bodydo not use longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor If

If condition persists or gets worse

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

For Rubbing And Massaging

Caution - Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes.

Directions

  • Clean the affected areaapply a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry first

Other Information

  • Does not contain, nor is intended as a substitute for grain or ethyl alcoholwill produce serious gastric distrubances if taken internally

Inactive Ingredient

Water, glycerin, Methyl salicylate

Made By

Made by: Unibeleza Industria e Comercio de Cosmeticos LtdaStreet: Dr. Alvaro Camargos, 2611/ Santa Monica-Belo Horizonte/MG - Brazil - Zip Code: 31.565-312Anvisa Operating License: 2.054292.2

* Please review the disclaimer below.