NDC 78850-104 Fresh Runy Antiseptic Wet Wipes

Benzalkonium Chloride

NDC Product Code 78850-104

NDC CODE: 78850-104

Proprietary Name: Fresh Runy Antiseptic 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

  • 78850 - Fulya Kozmetik Islak Mendil Imalat Ve Pazarlama Limited Sirketi

NDC 78850-104-01

Package Description: 72 PACKAGE in 1 PACKET > 3.6 g in 1 PACKAGE

NDC 78850-104-02

Package Description: 120 PACKAGE in 1 PACKET > 3.6 g in 1 PACKAGE

NDC Product Information

Fresh Runy Antiseptic Wet Wipes with NDC 78850-104 is a a human over the counter drug product labeled by Fulya Kozmetik Islak Mendil Imalat Ve Pazarlama Limited Sirketi. The generic name of Fresh Runy Antiseptic Wet Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Fulya Kozmetik Islak Mendil Imalat Ve Pazarlama 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.

Fresh Runy Antiseptic 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 .13 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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)

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: Fulya Kozmetik Islak Mendil Imalat Ve Pazarlama Limited Sirketi
Labeler Code: 78850
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: 09-03-2020 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.

Fresh Runy Antiseptic Wet Wipes Product Label Images

Fresh Runy Antiseptic 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

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

  • Hand wipes to decrease bacteria on the skinrecommended for repeated usefor use when soap and water are not available

Warnings

  • For external use onlyDo not usein children less than 2 months of ageon open skin woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask a doctor ifirritation and redness developcondition 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 resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to drydispose the wipe after usesupervise children under 6 years of age when using this product to avoid swallowingdo not flush

Other Information

  • Store between 15-30°C (59-86°F)avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water,

Other

ANTIBACTERIAL AGENTLong-Lasting ProtectionAlcohol free/ Paraben freeDermatological & Microbiological testedbalanced pHManufactured by: Fulya Kozmetik Islak Mendil                         Iml. ve Paz. Ltd. Sti.Kirac Osmanagazi Kucuk Ayazma Street No: 17, Esenyurt, Istanbul, TURKEY - 34522    Made in TURKEYYou may also report any serious side effects toPO Box 328, Wood Ridge, Nj 07075-328

* Please review the disclaimer below.