NDC 0904-6679 Major Bacitracin Zinc

Bacitracin Zinc

NDC Product Code 0904-6679

NDC 0904-6679-67

Package Description: 144 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC Product Information

Major Bacitracin Zinc with NDC 0904-6679 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Major Bacitracin Zinc is bacitracin zinc. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Major Pharmaceuticals

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.

Major 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 [USP'U]/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.

  • 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: Major Pharmaceuticals
Labeler Code: 0904
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: 09-28-2018 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.

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.

Major 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

Active Ingredients (In Each Gram)

Bacitracin 500

Purpose

First aid antibiotic

Uses

  • First aid to help prevent infection in minor:
  • Cuts
  • Scrapes
  • Burns

Warnings

For external use only

Allergy Alert:

  • Do not use if you are allergic to any of the ingredients

Do Not Use

  • In or near the eyes
  • On large areas of the body

Consult A Doctor Before Use If You Have

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

When Using This Product

  • Do not use longer than 1 week

Stop Use And Consult A Doctor If

  • Condition persists or gets worse
  • Symptoms last for more than 7 days or clear up and come back within a few days
  • A rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • Clean the affected area
  • Apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
  • May be covered with a sterile bandage

Other Information

  • Store at a controlled room temperature 20º-25ºC (68° to 77°F)

Inactive Ingredient

Petrolatum

* Please review the disclaimer below.