NDC 76725-008 Worldtec Disinfecting Wet Wipes

Benzalkonium Chloride

NDC Product Code 76725-008

NDC CODE: 76725-008

Proprietary Name: Worldtec Disinfecting 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: Benzalkonium Chloride 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

NDC 76725-008-01

Package Description: 100 PACKAGE in 1 PACKET > .3 g in 1 PACKAGE

NDC Product Information

Worldtec Disinfecting Wet Wipes with NDC 76725-008 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 Wet Wipes is benzalkonium chloride. 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 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.

  • BENZALKONIUM CHLORIDE .45 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)
  • POLIDOCANOL (UNII: 0AWH8BFG9A)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)

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: 08-29-2020 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’.

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Worldtec Disinfecting Wet Wipes Product Label Images

Worldtec Disinfecting 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

Name And Amount Of Active Substance (%)(W/W)

(Chemical name; CAS Number) Benzalkonium ChlorideCAS No: 85409-22-9 (0,45%)

Auxiliary Components % (W/W) (99,55)

Aqua, Laureth-9, Glycerin, Parfum, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid.

Purpose

ANTIBACTERIALANTI-FUNGAL

Indications & Usage

Use The product is developed for both personal and surface disinfection. It has a lethal effect on bacteria and germs

Warnings

DURING APPLICATION OR PREPARATION STAGE DO NOT EAT, DRINK, OR SMOKE TO AVOID RISKSON HUMAN AND ENVIRONMENTAL HEALTH FOLLOW INSTRUCTIONS FOR USAGE.It is poisonous to bees. It can be poisonous to fish and aquatic organisms.PRODUCT TYPE 1Biocidal product for human and surface hygiene..Symptoms of poisoningBenzalkonium chloride LD50 (oral, rat): 795 mg / kg First Aid Measures In case of inhalation: There is no danger.In case of eye contact: Rinse carefully with water for several minutes. Remove contact lenses if they are put on and easy to do. Continue rinsingIn case skin contact: This product is developed to contact with skin. Wash excess amount with water. In case of redness, swelling, itching, or burning get medical attention. In case of swallowing: Rinse mouth. Do not try to vomit. In case of unconsciousness, don't give anything from mouth. In case of vomiting, lay it on its back and turn it on its side. It has no specific antidote.CALL NATIONAL POISON CONSULTING CENTER IN THE EVENT OF POISONING. MATTERS TO BE CONSIDERED WHEN USING AND STORING THE PRODUCT HAZARDOUS EXPRESSION AND EXPLANATION.According to the Official Gazette No. 28848 (R.G. 11. 12.2013-28848) Local regulations are not classified as harmful under SEA and EU directives 1272/2008 / EC [CLP / GHS].PRECAUTIONARY STATEMENT AND EXPLANATIONP301 + P330 + P331 IF SWALLOWED: Rinse mouth. DO NOT try to vomit. P305 + P351 + P338 IF IN EYES: Rinse carefully with water for several minutes. Remove contact lenses if they are put on and easy to do. Continue rinsing.

Otc - Keep Out Of Reach Of Children

KEEP AWAY FROM CHILDREN, FOOD AND ANIMAL FEED.

How To Use

Take as much wet wipes as you need to clean the surface or skin.  You can use the product as often as required.

Storage And Handling

Other Information Empty package disposal method:Empty package should be sent for recycling or waste disposalP273: Avoid release to the environment. P391: Collect spillages. P101: If medical advice is needed, keep product container or label ready. P102: Keep away from reach of children. P103: Read the label before use. P410 + P235: Please do not expose to sunlight, store in a cool dry place.

* Please review the disclaimer below.