NDC 79262-110 Papilion Hygienic Antibacterial Hand Sanitizer

Alcohol

NDC Product Code 79262-110

NDC 79262-110-01

Package Description: 250 mL in 1 BOTTLE

NDC 79262-110-02

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Papilion Hygienic Antibacterial Hand Sanitizer with NDC 79262-110 is a a human over the counter drug product labeled by Ar Kagit San. Ve Tic. Ltd. Sti.. The generic name of Papilion Hygienic Antibacterial Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ar Kagit San. Ve Tic. Ltd. Sti.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Antibacterial Hand Sanitizer 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.

  • ALCOHOL 75 mL/100mL
  • ALCOHOL 75 mL/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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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.
  • 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: 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: 09-30-2020 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.

Papilion Hygienic Antibacterial Hand Sanitizer Product Label Images

Papilion Hygienic Antibacterial Hand Sanitizer 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

  • This 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) recommendations: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.Glycerol (0.5% v/v).Aloe Vera Leaf (0.1% v/v).Carbomer 940 (0.33% v/v).Triethanolamin (0.2% v/v).Sterile distilled waterThe 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

Purpose

Antiseptic, Papilion Hygienic Antibacterial Hand Sanitizer

Uses

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

Warnings

For external use only. Flammable. Keep away from fire or flame.

Otc - When Using

When 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 appears and lasts.

Otc - Stop Use

Stop use and ask a doctor if irritation or redness devolops and lasts.

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

  • Put enough product in your palm to cover hands and rub hands together until dry.Children under 6 years should be supervised when using this product.

Other Information

  • Store below 106 F (41 C).May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine.

* Please review the disclaimer below.