NDC 77457-000 Biotipo Pharma Medical Biogel

Alcohol

NDC Product Code 77457-000

NDC 77457-000-07

Package Description: 5000 mL in 1 BOTTLE, PLASTIC

NDC 77457-000-09

Package Description: 5000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Biotipo Pharma Medical Biogel with NDC 77457-000 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 Biogel is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Unibeleza Industria E Comercio De Cosmeticos Ltda

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Biogel 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 .7 mL/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • COUMARIN (UNII: A4VZ22K1WT)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CAMPHOR LEAF OIL (UNII: 51D0RGY52V)

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: 07-03-2020 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 Biogel 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% v/v

Purpose

Antiseptic

Uses

Hand Sanitizer to Help reduce Bacteria on the skin. The 


Biotipo Pharma Medical BioGel Alcohol Gel 70% Antiseptic Aloe Vera Hand Sanitizer is used as a complement to routine hand cleaning. Without rinising, it leaves no fragrance residue and eliminates 99.99% of germs in the region.

Warnings:

Flammable Product. Keep away from source of heat, fire or flame. FLammable product can cause burns.For External Use Only.

When Using This Product

avoid direct contact with eyes and mucous membranes. If contact occurs. Rinse with water. Do not ingest the product.

Stop Use And Ask A Doctor If

Irritation or redness develops and lasts

Keep Out Of Reach Of Children

Keep out of reach of children, in case of accidental ingestion, get medical help or contact a Poison control center or Health Services immediately.

Directions:

-Apply a small amount of 


Biotipo Pharma Medical BioGel Alcohol Gel 70% Antiseptic Aloe Vera on the palm of the hand and rub until dry. No water or towel is required.


-Children under 6 years should be supervised when using this product.-


DO NOT SWALLON - containes denaturant. THe product contains  VEGETABLE GLYCERINE as a denturant

Inactive Ingredients

Aqua(Water), Vegetable Glycerin, Carbomer, Triethanolamine, Parfum, Benzyl Salicylate, Linalool, Limonene, Hidroxycitronellal, Coumarin, Tocophrryl Acetate, Aloe Babarbadensis Leaf Juice, Cinnamomun Camphora Leaf oil.

Other Information.

Store at a temperature below 110°F (43%).May discolor certain fabrics of surfaces.Keep the product in its original packing.

Otc - Questions

​Questions or Comments: 1 617-710-8020

* Please review the disclaimer below.