NDC 80793-003 Targol Alcohol Wipes - Fresh Scent

Ethyl Alcohol

NDC Product Code 80793-003

NDC CODE: 80793-003

Proprietary Name: Targol Alcohol Wipes - Fresh Scent 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

  • 80793 - Hedef Kimya Sanayi Ve Ticaret Anonim Sirketi
    • 80793-003 - Targol Alcohol Wipes - Fresh Scent

NDC 80793-003-01

Package Description: 72 PACKAGE in 1 PACKET > 3.75 g in 1 PACKAGE

NDC Product Information

Targol Alcohol Wipes - Fresh Scent with NDC 80793-003 is a a human over the counter drug product labeled by Hedef Kimya Sanayi Ve Ticaret Anonim Sirketi. The generic name of Targol Alcohol Wipes - Fresh Scent is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Hedef Kimya Sanayi Ve Ticaret Anonim Sirketi

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Targol Alcohol Wipes - Fresh Scent 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 75 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)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Hedef Kimya Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 80793
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: 10-19-2020 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.

Targol Alcohol Wipes - Fresh Scent Product Label Images

Targol Alcohol Wipes - Fresh Scent 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 75%

Purpose

Antiseptic

Uses

• hand wipes to decrease bacteria and germs on the skin.• recommended for repeated use.• for use when soap and water are not available

Warnings

For external use onlyDo not use• in children less than 2 months of age• on open skin woundsWhen using this product • do not get into eyes. In case of eye contact, rinse eyes thoroughly with water.Stop use and ask a doctor if• irritation or redness develop• condition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe and allow to dry, discard after use.• Supervise children under 6 years of age when using this product"

Other Information

• Store at room temperature.• Keep tightly closed when not use to keep moisture.• Dispose of used wipe in trash. Do not flush

Inactive Ingredients

Aqua, parfum, glycerin

* Please review the disclaimer below.