NDC 78090-411 Diarte 20/20 Antiseptic Hand Sanitizer

Ethyl Alcohol

NDC Product Code 78090-411

NDC CODE: 78090-411

Proprietary Name: Diarte 20/20 Antiseptic Hand Sanitizer 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: Ethyl 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

  • 78090 - Ls Professional Services International Inc
    • 78090-411 - Diarte 20/20 Antiseptic Hand Sanitizer

NDC 78090-411-95

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Diarte 20/20 Antiseptic Hand Sanitizer with NDC 78090-411 is a a human over the counter drug product labeled by Ls Professional Services International Inc. The generic name of Diarte 20/20 Antiseptic Hand Sanitizer is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ls Professional Services International Inc

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.

Diarte 20/20 Antiseptic 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 80 mL/100mL

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)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • 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: Ls Professional Services International Inc
Labeler Code: 78090
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: 05-28-2020 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.

Diarte 20/20 Antiseptic Hand Sanitizer Product Label Images

Diarte 20/20 Antiseptic 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 80%

Purpose

Antiseptic

Uses

  • Hand sanitizer to decrease bacteria on the skinrecommended for repeated usefor use when soap and water are not available

Warnings

  • Flammable, keep away from fire/flameFor external use onlyDo not usein children less than 2 months of ageon open skin woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with waterStop use and ask a doctor ifirritation and redness developcondition persists for more than 72 hours

Directions

  • Wet hands thoroughly with product and allow to dry without wipingsupervise children under 6 years of age when using this product to avoid swallowing

Other Information

  • Store between 15-30°C (59-86°F)avoid freezing and excessive heat above 40°C (104°F)

* Please review the disclaimer below.