NDC 80214-004 Hygipart Antiseptc


NDC Product Code 80214-004

NDC 80214-004-01

Package Description: 400 g in 1 BOTTLE, PLASTIC

NDC Product Information

Hygipart Antiseptc with NDC 80214-004 is a a human over the counter drug product labeled by Mod Design Build. The generic name of Hygipart Antiseptc is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Mod Design Build

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.

Hygipart Antiseptc 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 g/100g

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)

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.

Product Labeler Information

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

Labeler Name: Mod Design Build
Labeler Code: 80214
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: 03-20-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hygipart Antiseptc Product Label Images

Hygipart Antiseptc 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

Alcohol 70%


Antiseptic gel


Hygipart is an antiseptic gel for hand hygiene and hydration, the effectiveness is 99,99% for

microorganisms: Salmonella choleraesuis, Staphylococcus aureus and Pseudomonas aeruginosa.


Keep out of reach of children.

- This product does not replace soap and water washing.

- Flammable.

- Keep the product in its original packaging and away from heat and flames.

- Do not use in critical hospital areas (surgical areas).

- Do not reuse the empty packaging.

-Store at room temperature (15- 30°C}, away from heat and direct natural light.

- Keep away from fire and heat.

- Do not pierce the cover.

- Don't spill over the fire.

-In case of burn, wash the area with running water.

- In case of ingestion, do not induce vomiting and immediately consult the poison center or the

nearest health service.

- Not ingest- contains denaturant.

-The product contains "Denatonium Benzoate" as a denaturant.


Apply a small amount of Hygipart on your hands and spread until completely absorbed.

Inactive Ingredients



* Please review the disclaimer below.