NDC 79262-130 Papilion Hygienic Alcohol Wipes Antibacterial

Alcohol

NDC Product Code 79262-130

NDC CODE: 79262-130

Proprietary Name: Papilion Hygienic Alcohol Wipes Antibacterial 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: Alcohol 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

  • 79262 - Ar Kagit San. Ve Tic. Ltd. Sti.
    • 79262-130 - Papilion Hygienic Alcohol Wipes Antibacterial

NDC 79262-130-02

Package Description: 64 PATCH in 1 PACKAGE > 2.916 mL in 1 PATCH (79262-130-01)

NDC Product Information

Papilion Hygienic Alcohol Wipes Antibacterial with NDC 79262-130 is a a human over the counter drug product labeled by Ar Kagit San. Ve Tic. Ltd. Sti.. The generic name of Papilion Hygienic Alcohol Wipes Antibacterial is alcohol. The product's dosage form is cloth and is administered via topical form.

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.

Papilion Hygienic Alcohol Wipes Antibacterial 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ar Kagit San. Ve Tic. Ltd. Sti.
Labeler Code: 79262
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: 10-24-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Papilion Hygienic Alcohol Wipes Antibacterial 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

Papilion HYGIENIC ALCOHOL WIPESANTIBACTERIALEXTA PROTECTION AND CLEANINGREDUCE 99% OF GERMS & BACTERIAThis is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.2. ALOE BARBADENSIS EXTRCT (0.1 % v/v).

3. GLYCERIN (0.5 % v/v).

4. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Alcohol 75% v/v. Purpose: Antiseptic/ Antiviral

Purpose

Papilion HYGIENIC ALCOHOL WIPESANTIBACTERIAL

Uses

Alcohol wipes to help reduce bacteria that potentially can cause disease.

Warnings

For external use only.Do not usein children less than 2 months of ageOn open skin woundsWhen using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

When using this product, do not use in or near the eyes. In case of contact, rinse eyes 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

Open package, remove one wet wipe to clean your hands and body. Reseal, keep closed to prevent evaporation.Allow to dry without wiping. Discard propearly after use.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store at room temperatureDo not flush down toilet.

Inactive Ingredients

Water, Glycerin, Aloe barbadensis Extract.

* Please review the disclaimer below.