NDC 63940-540 Face Values Bacitracin

Bacitracin

NDC Product Code 63940-540

NDC 63940-540-28

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Face Values Bacitracin with NDC 63940-540 is a a human over the counter drug product labeled by Harmon Stores Inc.. The generic name of Face Values Bacitracin is bacitracin. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1648110.

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.

Face Values Bacitracin 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • 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: Harmon Stores Inc.
Labeler Code: 63940
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: 04-01-2012 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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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]

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Face Values Bacitracin Product Label Images

Face Values Bacitracin 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

Otc - Active Ingredient

Active ingredients (each gram contains)                                                         PurposeBacitracin 500 units .......................................................................................First Aid Antibiotic

Otc - Purpose

Usesfirst aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not usein the eyesif you are allergic to any of the ingredientsover large areas of the bodylonger than 1 week unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

  • Stop use and ask a doctor ifthe 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

Indications & Usage

  • Directionsclean the affected areaapply 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

Storage And Handling

  • Other informationstore at 15o to 25o C (59o to 77o F)Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredientsdecolorized aloe vera gel, light mineral oil, white petrolatum

Dosage & Administration

Distributed byLiberty Procurement, Inc.650 Liberty AvenueUnion, NJ 07083 USAMade in Korea

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