NDC 65601-796 Advanced Alcohol Gel Sanitizer

Alcohol

NDC Product Code 65601-796

NDC Code: 65601-796

Proprietary Name: Advanced Alcohol Gel Sanitizer 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

  • 65601 - Betco Corporation, Ltd
    • 65601-796 - Advanced Alcohol Gel Sanitizer

NDC 65601-796-19

Package Description: 900 mL in 1 BAG

NDC 65601-796-29

Package Description: 1000 mL in 1 BAG

NDC 65601-796-57

Package Description: 550 mL in 1 BOTTLE, PUMP

NDC Product Information

Advanced Alcohol Gel Sanitizer with NDC 65601-796 is a a human over the counter drug product labeled by Betco Corporation, Ltd. The generic name of Advanced Alcohol Gel Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Betco Corporation, Ltd

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.

Advanced Alcohol Gel 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 1 mL/.7mL

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)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETOL (UNII: Q4R969U9FR)

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: Betco Corporation, Ltd
Labeler Code: 65601
FDA Application Number: part333E 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: 08-01-2019 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: 12-31-2020 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.

Advanced Alcohol Gel Sanitizer Product Label Images

Advanced Alcohol Gel 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

Active Ingredient

Active IngredientEthyl Alcohol 70%

Uses

Uses• Hand sanitizer to reduce microorganisms on the skin.• Use this product when soap and water are not available.

Purpose

PurposeAntiseptic

Warnings

Warnings• For external use only.• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.• FLAMMABLE. This product contains ethyl alcohol. Keep away fromsources of ignition.• Discontinue use if irritation or redness develops.• If irritation persists for more than 72 hours, consult a physician.• KEEP OUT OF REACH OF CHILDREN.• If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN.

Directions

Directions• Read the entire label before using this product.• Place enough product on your palm to thoroughly cover your hands.• Rub hands together briskly until dry.

Inactive Ingredients

Inactive IngredientsWater, PEG/PPG-8/3 Laurate, Gycerin, Carbomer, Tetrahydroxypropylethylendiamine, Fragrance.

* Please review the disclaimer below.

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