NDC 52000-059 Bacitracin Zinc

Bacitracin Zinc

NDC Product Code 52000-059

NDC 52000-059-01

Package Description: 1 TUBE in 1 CARTON > 14 g in 1 TUBE

NDC Product Information

Bacitracin Zinc with NDC 52000-059 is a a human over the counter drug product labeled by Universal Distribution Center Llc. The generic name of Bacitracin Zinc is bacitracin zinc. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Universal Distribution Center Llc

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.

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.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • WHITE PETROLATUM (UNII: B6E5W8RQJ4)

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: Universal Distribution Center Llc
Labeler Code: 52000
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: 12-09-2020 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.

Bacitracin Zinc Product Label Images

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

Active Ingredient

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

Uses

  • First aid to help prevent infection in scrapes   minor cutsburns

Warnings

EXTERNAL USE ONLY

Do Not Use

  • In the eyes  if you are allergic to any of the ingredientsover large areas of the bodylonger than 1 week unless directed by a doctor

Before Using, Consult A Doctor If You Have

  • Deep or puncture wounds animal bites
  • Serious burns

Stop Use And Ask A Doctor If

  • You need to use longer than 1 weekcondition persists or gets worse symptoms persists for more than 1 week or clear up and occur again within a few days a rash or other allergic reaction develops

Keep Out Of Reach Of Children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • Clean affected area
  • Apply 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 daily  may be covered with a sterile bandage

Other Information

  • Store at room temperature 15° to 25°C (59° to 77°F).   Before using any medication, read all label directions.Keep carton, it contains important information.Lot No./Exp. Date: see crimp of tube.

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

* Please review the disclaimer below.