NDC 79781-216 Molecure Skincare Alcohol Wipes

Ethyl Alcohol

NDC Product Code 79781-216

NDC CODE: 79781-216

Proprietary Name: Molecure Skincare Alcohol 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

  • 79781 - Molecule Koruyucu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi

NDC 79781-216-01

Package Description: 80 PACKAGE in 1 CANISTER > 4.2 mL in 1 PACKAGE

NDC Product Information

Molecure Skincare Alcohol Wipes with NDC 79781-216 is a a human over the counter drug product labeled by Molecule Koruyucu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi. The generic name of Molecure Skincare Alcohol Wipes is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Molecule Koruyucu Saglik Urunleri 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.

Molecure Skincare Alcohol 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 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.

  • 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: Molecule Koruyucu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 79781
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: 11-06-2020 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.

Molecure Skincare Alcohol Wipes Product Label Images

Molecure Skincare Alcohol 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 (80%)

Purpose

Hand Sanitizing

Uses

- hand sanitizer to decrease bacteria on the skin- recommended for repeated use

Warnings

Flammable, keep away from fire / flame For external use onlyDo NOT dispose in toilet to avoid clogging.Keep in cool place indoors avoid high temperature and direct sunlight. Do NOT throw on fire.When using this product.- do not get into eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if.- irritation and 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

Open the cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist. adults and children 12 years and over Use as directed children 6 years to under 12 years Use as directed children under 6 years ask a doctor

Other Information

• do not store in direct sunlight• store at 20-25° C (68-77° F)• protect from excessive moisture

Inactive Ingredients:

Water, glycerine

Questions: +19174151404

"You may also report serious side effects to this phone number.(Mon-Fri 9:00 AM - 5:00 PM)"

* Please review the disclaimer below.