NDC 76964-901 Juicey Antibacterial Hand Wipes

Benzalkonium Chloride

NDC Product Code 76964-901

NDC CODE: 76964-901

Proprietary Name: Juicey Antibacterial Hand 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

  • 76964 - Tat Kimya Sabun Ve Gliserin Sanayi Ve Ticaret Anonim Sirketi

NDC 76964-901-01

Package Description: 60 POUCH in 1 PACKAGE > 5 g in 1 POUCH

NDC Product Information

Juicey Antibacterial Hand Wipes with NDC 76964-901 is a a human over the counter drug product labeled by Tat Kimya Sabun Ve Gliserin Sanayi Ve Ticaret Anonim Sirketi. The generic name of Juicey Antibacterial Hand Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Tat Kimya Sabun Ve Gliserin 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.

Juicey Antibacterial Hand 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • C12-15 PARETH-12 (UNII: 131316X18L)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Tat Kimya Sabun Ve Gliserin Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 76964
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: 10-28-2020 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.

Juicey Antibacterial Hand Wipes Product Label Images

Juicey Antibacterial Hand 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(S)

Benzalkonium Chloride %0.25 w/w. Purpose : Antibacterial

Purpose

Antibacterial, Wet Wipes

Use

Antibacterial wet wipes helps reduce bacteria (organisms).Effective on bacterias :Staphylococcus aureus ATCC 6538,Pseudomonas aeruginosa ATCC 15442,Enterococcus hirae ATCC 10541,Escherichia coli ATCC 10536

Warnings

Keep away from children and direct sunlight. Children should not use this product without an adult supervision. For external use only. In case of poisoning, call the National Toxitation Information Center. Awoid contact with eyes.

Do Not Use

Do not use with eyes. For external use only.

Otc - When Using

In case of inhaling: If you feel uncomfortable get some fresh ait. In case of skin Irritation: Occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. People with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. Seek for medical advice if necessary. In case of contact with eyes: If you are wearing contact lenses, remove them immediately. Rince your eyes with plenty of clean water. In case of swallowing: Call your local Toxication Center and get medical help. There is no specific antidote therefore treatment must be done according to symptoms. Treatment: Treatment is indicated according to the indication. CALL YOUR LOCAL POISON CENTER.

Otc - Stop Use

Treatment is indicated according to the indication. CALL YOUR LOCAL POISON CENTER

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Children should not use this product without an adult supervision.

Directions

Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required. User group : General public

Other Information

Store in a cool and dry place.

Inactive Ingredients

Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate, Panthenol, Citric Acid, Aloe Barbadensis Leaf Extract

* Please review the disclaimer below.