NDC 0179-8012 Kaiser Permanente Bacitracin Zinc

Bacitracin Zinc

NDC Product Code 0179-8012

NDC 0179-8012-30

Package Description: 1 TUBE in 1 CARTON > 28.4 g in 1 TUBE

NDC Product Information

Kaiser Permanente Bacitracin Zinc with NDC 0179-8012 is a a human over the counter drug product labeled by Kaiser Foundation Hospitals. The generic name of Kaiser Permanente Bacitracin Zinc is bacitracin zinc. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Kaiser Foundation Hospitals

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Kaiser Permanente Bacitracin Zinc 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.

  • BACITRACIN ZINC 500 [iU]/g

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.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Kaiser Foundation Hospitals
Labeler Code: 0179
FDA Application Number: part333B 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-11-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Information for Patients

Bacitracin Topical

Bacitracin Topical is pronounced as (bass i tray' sin)

Why is bacitracin topical medication prescribed?
Bacitracin is used to help prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Bacitracin is in a class of medications called antibiotics...
[Read More]

* Please review the disclaimer below.

Kaiser Permanente Bacitracin Zinc Product Label Images

Kaiser Permanente Bacitracin Zinc 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

Drug Facts

Manufactured byTaro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1Distributed byKaiser Foundation HospitalsLivermore, CA 94551-9756

Active Ingredient (Each Gram Contains)

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

Uses

  • First aid to help prevent infection inminor cutsscrapesburns

Warnings

For external use only

Do Not Use

  • In the eyesover large areas of the bodyif you are allergic to any of the ingredientslonger than 1 week unless directed by a doctor

Ask A Doctor Before Use

  • On deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

  • Condition persists or gets worsea rash or other allergic reaction develops

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

  • Clean the affected area and dry thoroughlyapply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailymay be covered with a sterile bandage

Other Information

  • To open: unscrew cap, pull tab to remove foil sealstore at room temperaturesee carton or tube crimp for lot number and expiration date

Inactive Ingredients

Mineral oil, white petrolatum

Questions?

Call 1-866-923-4914

* Please review the disclaimer below.