NDC 78089-032 Abutol Antiseptic Wet Wipes English Lavender Scent

Benzalkonium Chloride

NDC Product Code 78089-032

NDC CODE: 78089-032

Proprietary Name: Abutol Antiseptic Wet Wipes English Lavender Scent 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

  • 78089 - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
    • 78089-032 - Abutol Antiseptic Wet Wipes English Lavender Scent

NDC 78089-032-01

Package Description: 72 PACKAGE in 1 PACKET > 4.11 g in 1 PACKAGE

NDC Product Information

Abutol Antiseptic Wet Wipes English Lavender Scent with NDC 78089-032 is a a human over the counter drug product labeled by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi. The generic name of Abutol Antiseptic Wet Wipes English Lavender Scent is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Endeks Kimya 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.

Abutol Antiseptic Wet Wipes English Lavender Scent 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.


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)
  • CORN OIL (UNII: 8470G57WFM)

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: Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 78089
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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Abutol Antiseptic Wet Wipes English Lavender Scent Product Label Images

Abutol Antiseptic Wet Wipes English Lavender Scent 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%




  • Hand wipes to decrease bacteria on the skin.recommended for repeated use.for use when soap and water are not available


  • 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 eye contact, rinse eyes thoroughly with water.Stop use and ask a doctor ifirritation or 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


  • 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

Aqua, Glycerin, Propylene glycol, Parfum, Polysorbate-20, Cocamidopropyl Betaine, Corn Oil, Lauryl Glucoside, Polyglyceryl-2 DipolyhydroxyStearate, Glyceryl Oleate, Dicaprylyl Carbonate, Tetrasodium EDTA, Phenoxyethanol, Benzoic Acid, Dehydroacetic acid.


  • PARISENGLISH LAVENDER SCENTSANITIZING WIPESYou may also report any serious side effects toPO Box 328, Wood Ridge, NJ 07075-328 ANTISEPTIC AGENTSanitizing formula to help reduce cross-contamination and risk of infection.Leaves no stickiness or residue on hands.Hands feel smooth, soft and refreshed.To Open PackageFlip open dispensing lidLocate wipe at center of roll and thread through small opening in lidFor best results dispense wipes at an angleAlways close lid securely between uses to retain moistureMade in TURKEYTO DISPOSE WIPE: Place in a waste basket after use.DO NOT FLUSHLot Number and Exp Date on package

* Please review the disclaimer below.