Biotipo Pharma Medical Biogel
Alcohol
Unibeleza Industria E Comercio De Cosmeticos Ltda
Human Otc Drug
NDC 77457-001Biotipo Pharma Medical Biogel also known as Alcohol is a human otc drug labeled by 'Unibeleza Industria E Comercio De Cosmeticos Ltda'. National Drug Code (NDC) number for Biotipo Pharma Medical Biogel is 77457-001. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Biotipo Pharma Medical Biogel drug includes Alcohol - .7 mL/mL . The currest status of Biotipo Pharma Medical Biogel drug is Active.
Drug Information:
| Drug NDC: | 77457-001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Biotipo Pharma Medical Biogel |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Unibeleza Industria E Comercio De Cosmeticos Ltda |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ALCOHOL - .7 mL/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 08 Jul, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 22 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Unibeleza Industria e Comercio de Cosmeticos Ltda
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 581662
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 7898471745208
|
| UPC stands for Universal Product Code. |
| UNII: | 3K9958V90M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 77457-001-01 | 50 mL in 1 BOTTLE, PLASTIC (77457-001-01) | 08 Jul, 2020 | 31 Aug, 2023 | No |
| 77457-001-02 | 100 mL in 1 BOTTLE, PLASTIC (77457-001-02) | 08 Jul, 2020 | 31 Aug, 2023 | No |
| 77457-001-03 | 200 mL in 1 BOTTLE, PLASTIC (77457-001-03) | 08 Jul, 2020 | 31 Aug, 2023 | No |
| 77457-001-04 | 250 mL in 1 BOTTLE, PLASTIC (77457-001-04) | 08 Jul, 2020 | 31 Aug, 2023 | No |
| 77457-001-05 | 500 mL in 1 BOTTLE, PLASTIC (77457-001-05) | 08 Jul, 2020 | 31 Aug, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic
Product Elements:
Biotipo pharma medical biogel alcohol water glycerin carbomer homopolymer, unspecified type trolamine benzyl salicylate linalool, (+/-)- limonene, (+)- hydroxycitronellal coumarin .alpha.-tocopherol acetate aloe vera leaf camphor leaf oil alcohol alcohol
Indications and Usage:
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:
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.
When Using:
When using this product avoid direct contact with eyes and mucous membranes. if contact occurs. rinse with water. do not ingest the product.
Dosage and Administration:
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 denaturant
Stop Use:
Stop use and ask a doctor if irritation or redness develops and lasts
Package Label Principal Display Panel:
Package labeling 50ml biotipo 050ml
Package labeling 100ml biotipo 100ml
Package labeling 200ml biotipo200ml
Package labeling 250ml biotipo 250ml
Package lableing 500ml biotipo 500ml
Further Questions:
âquestions or comments: 1 617-710-8020