NDC 79781-217 Molecure Skincare Disinfectant Hand And Skin Wet Wipe

Benzalkonium Chloride, Alcohol

NDC Product Code 79781-217

NDC CODE: 79781-217

Proprietary Name: Molecure Skincare Disinfectant Hand And Skin Wet Wipe 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: Benzalkonium Chloride, 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 79781-217-01

Package Description: 45 PACKAGE in 1 CANISTER > 7.67 mL in 1 PACKAGE

NDC 79781-217-02

Package Description: 100 PACKAGE in 1 CANISTER > 7.67 mL in 1 PACKAGE

NDC Product Information

Molecure Skincare Disinfectant Hand And Skin Wet Wipe with NDC 79781-217 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 Disinfectant Hand And Skin Wet Wipe is benzalkonium chloride, 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 Disinfectant Hand And Skin Wet Wipe 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.

  • BENZALKONIUM CHLORIDE .33 g/100mL
  • 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)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: 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: 12-26-2020 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: 12-31-2022 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’.

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Molecure Skincare Disinfectant Hand And Skin Wet Wipe Product Label Images

Molecure Skincare Disinfectant Hand And Skin Wet Wipe 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

Name And Dosage Of The Active Ingredient

ALKYLDIMETHYLBENZYLAMMONIUM CHLORIDE (50% w/w): 0.33%ALCOHOL (96.50 % w/w): 80%

Purpose

Antiseptic

Warnings

KEEP AWAY FROM FOOD AND ANIMAL FEEDS, DO NOT EAT, DRINK AND SMOKE DURING THE APPLICATION AND PREPARATION. KEEP AWAY FROM HEAT OR OPEN FLAME.Hazard Statements : Highly flammable liquid and vapour. Toxic to aquatic life. Harmful to aquatic life with long lasting effects.Precaution Statements :Keep away from heat, sparks, open flames and hot surfaces. No smoking. Avoid release to the environment.Dispose of contents/ container in accordance with national regulations.- No smoking.

Other Ingredients :

Aqua, Coco Glucoside, Allantoin, Citric Acid

Directions For Storage And Use :

• Avoid contact with the eyes. Read and follow manufacturer's recommendations.• Throw the wipes in the rubbish bin after use.• Store it in its original packaging in a dry and cool place.• Keep away from direct light and sunlight.• It might be toxic to fish and aquatic organisms.Container Disposal :Dispose of Contents / Container In accordance with Local / National / International Regulations

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