NDC 76725-015 Worldtec Disinfecting 70% Alcohol Wet Wipes

Ethyl Alcohol

NDC Product Code 76725-015

NDC CODE: 76725-015

Proprietary Name: Worldtec Disinfecting 70% Alcohol Wet Wipes 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

  • 76725 - Makyaj Kozmetik Insaat Sanayi Ve Ticaret Limited Sirketi
    • 76725-015 - Worldtec Disinfecting 70% Alcohol Wet Wipes

NDC 76725-015-01

Package Description: 40 PACKAGE in 1 PACKET > .3 g in 1 PACKAGE

NDC Product Information

Worldtec Disinfecting 70% Alcohol Wet Wipes with NDC 76725-015 is a a human over the counter drug product labeled by Makyaj Kozmetik Insaat Sanayi Ve Ticaret Limited Sirketi. The generic name of Worldtec Disinfecting 70% Alcohol Wet Wipes is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Makyaj Kozmetik Insaat Sanayi Ve Ticaret Limited 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.

Worldtec Disinfecting 70% Alcohol Wet Wipes 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 67 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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • 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: Makyaj Kozmetik Insaat Sanayi Ve Ticaret Limited Sirketi
Labeler Code: 76725
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: 09-22-2020 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.

Worldtec Disinfecting 70% Alcohol Wet Wipes Product Label Images

Worldtec Disinfecting 70% Alcohol Wet Wipes 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 67%

Purpose

Antiseptic

Uses

• For hand sanitizing to decrease bacteria and germs on skin.• Apply topically to the skin to help prevent cross contamination.• Dries in seconds.

Warnings

• For external use only. Harmful if swallowed.• Do not use as baby wipes.• Do not flush down the toilet. Highly flammable.• Keep away from fire or flame. Do not use in or contact the eyes. Avoid contact with open or exposed wounds.Do Not Use• Do not use as baby wipes.• Do not flush down the toilet.• Highly flammable. Keep away from fire or flame.• Do not eat or drink when handling.• Avoid contact with open or exposedWhen UsingKeep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with waterStop UseStop use if too much skin irritation and sensitivity develops or increases

Keep Out Of Reach Of Children

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

Directions

• Lift the tab on top of the lid to open.• Open moisture seal film package before use.• Pull out first wipe through the dispensing center of the canister.Next sheets pops up automatically• Close the lid to retain moisture.• Wipe clean with this product. Let air dry

Other Informations

• Store at room temperature 15-30°C (59-86°F).• Lot No. Manufacture date and expiration date can be found on package.

* Please review the disclaimer below.