NDC 81182-000 Pureza Advanced Hand Sanitizer

Alcohol

NDC Product Code 81182-000

NDC 81182-000-01

Package Description: 80 mL in 1 BOTTLE

NDC 81182-000-02

Package Description: 200 mL in 1 BOTTLE

NDC 81182-000-03

Package Description: 500 mL in 1 BOTTLE

NDC 81182-000-04

Package Description: 1000 mL in 1 BOTTLE

NDC 81182-000-05

Package Description: 3780 mL in 1 BOTTLE

NDC Product Information

Pureza Advanced Hand Sanitizer with NDC 81182-000 is a a human over the counter drug product labeled by Industrias Coramodio C.a. The generic name of Pureza Advanced Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Industrias Coramodio C.a

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.

Pureza Advanced Hand Sanitizer 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Industrias Coramodio C.a
Labeler Code: 81182
FDA Application Number: part333E 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: 01-01-2021 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: 12-31-2021 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.

Pureza Advanced Hand Sanitizer 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

Antimicrobial

Uses

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use

Warnings

Flammable. keep away from fire or flame.For external use only

When Using This Product

Do not use in or near the eyes. In case of contact, rinse eyes throroughly with water.

Stop Use And Ask A Doctor If

Irritation or rash appears os ojos con agua. and lasts

Keep Out Of Reach Of Children.

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

Directions

• Place enough product in your palm to thoroughly cover your hands • Rub hands together briskly until dry • No rinsing required • No towels needed

Other Information

• Store below 110ºF (43ºC)


• May discolor certain fabrics or surfaces

Inactive Ingredients

Alcohol, Water, Isopropyl Alcohol, Glycerin, Carbomer, Triethanolamine, Fragance.

* Please review the disclaimer below.