NDC 79320-122 Geniuscare Antibacterial Wet Wipes

Benzalkonium Chloride

NDC Product Code 79320-122

NDC CODE: 79320-122

Proprietary Name: Geniuscare Antibacterial 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

  • 79320 - Rk Kozmetik Ve Hijyen Urunleri Sanayi Dis Ticaret Anonim Sirketi
    • 79320-122 - Geniuscare Antibacterial Wet Wipes

NDC 79320-122-01

Package Description: 72 mL in 1 BAG

NDC Product Information

Geniuscare Antibacterial Wet Wipes with NDC 79320-122 is a a human over the counter drug product labeled by Rk Kozmetik Ve Hijyen Urunleri Sanayi Dis Ticaret Anonim Sirketi. The generic name of Geniuscare Antibacterial Wet Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Rk Kozmetik Ve Hijyen Urunleri Sanayi Dis 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.

Geniuscare Antibacterial 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 mg/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.

  • CHLORHEXIDINE (UNII: R4KO0DY52L)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • EDETATE SODIUM (UNII: MP1J8420LU)

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: Rk Kozmetik Ve Hijyen Urunleri Sanayi Dis Ticaret Anonim Sirketi
Labeler Code: 79320
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: 10-03-2020 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.

Geniuscare Antibacterial Wet Wipes Product Label Images

Geniuscare Antibacterial 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

Other

ANTIBACTERIAL WET WIPESPerfect for quick clean-ups when soap and water are not available.Genius Care Wet Wipes ANTIBACTERIAL SOFT GENTLE HAND WIPESREDUCES 99.0% OF BACTERIA*72 TRAVEL PACK THICK & SOFT CLOTHSALCOHOL, PARABEN & TRICLOSAN FREEANTIBACTERIAL WET WIPESTravel Pack is convenient to carry for use anytime, anywhere.*Reduces 99.9% of bacterial and fungal strains as tested in a laboratory setting ( Staphylococcus aureus)(Pseudomonas aeruginosa)(Escherichia coli)(Enterococcus hirae)(Candida albicans)

Active Ingredient(S)

Benzalkonium chloride 0.1 %. Purpose: Antiseptic

Purpose

Antiseptic, GeniusCareGenius Care Wet Wipes ANTIBACTERIAL SOFT GENTLE HAND WIPES

Uses

To Dispense Wipe: Peel back front label slowly. Remove wipes.To Reseal Pouch: Firmly run thumb over the label.Do not Flush

Warnings

For external use only.Do not use if you are allergic to any of the ingredientsWhen using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Ask a doctor before use

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash develops and continues 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

For use by adults and children 2 years and overUse decreases bacteria on skin.Apply to hands

Allow to dry without wiping

Other Information

DO NOT FLUSH

Inactive Ingredients

Water, Propylene Glycol, Cocamidopropyl Betain, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Benzoic Acid, Dehydroxyacetic Acid, Fragrance, PEG-40 Hdrogenated Castor Oil, Tetrasodium EDTA, Chlorhexidin Digluconat, Citric Acid.

* Please review the disclaimer below.