NDC 77613-012 G And Y Disinfecting Wet Wipes

Benzalkonium Chloride

NDC Product Code 77613-012

NDC CODE: 77613-012

Proprietary Name: G And Y 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

  • 77613 - Eruslu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi

NDC 77613-012-90

Package Description: 90 PACKET in 1 PACKAGE > 3.8 mL in 1 PACKET

NDC Product Information

G And Y Disinfecting Wet Wipes with NDC 77613-012 is a a human over the counter drug product labeled by Eruslu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi. The generic name of G And Y Disinfecting Wet Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Eruslu 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.

G And Y 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 .2 g/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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)
  • C12-15 PARETH-12 (UNII: 131316X18L)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

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: Eruslu Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 77613
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: 07-03-2020 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.

G And Y Disinfecting Wet Wipes Product Label Images

G And Y 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

Active Ingredients

Benzalkonium Chloride 0.2% w/w

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin

Warning

For external use onlyDo not use▪ in the eyes.▪ if you are allergic to any of the ingredients.When using this product  if eye contact occurs, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation and redness develop and persist 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

• Storage. Store at room temperature.• Dispensing. Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture.• Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.• Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

Other Information

Production Date, Expiry Date and Lot Number on side

Inactive Ingredients

Benzoic Acid, C12-14-Alkyldimethyl(Ethylbenzyl)Ammonium Chloride, C12-15 Pareth-12, Dehydroacetic Acid, Didecyl Dimethyl Ammonium Chloride, Ethyl Alcohol, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate,

* Please review the disclaimer below.