NDC 50382-023 Triple Antibiotic

Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate

NDC Product Code 50382-023

NDC 50382-023-11

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

NDC 50382-023-12

Package Description: 1 TUBE in 1 CARTON > 14.2 g in 1 TUBE

NDC 50382-023-13

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

NDC Product Information

Triple Antibiotic with NDC 50382-023 is a a human over the counter drug product labeled by Galentic Pharma (india) Private Limited. The generic name of Triple Antibiotic is bacitracin zinc, neomycin sulfate, and polymyxin b sulfate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Galentic Pharma (india) Private Limited

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.

Triple Antibiotic 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 400 [iU]/g
  • NEOMYCIN SULFATE 5 mg/g
  • POLYMYXIN B SULFATE 5000 [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.

  • 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: Galentic Pharma (india) Private Limited
Labeler Code: 50382
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: 08-07-2013 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

Neomycin, Polymyxin, and Bacitracin Topical

Neomycin, Polymyxin, and Bacitracin Topical is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)

Why is neomycin, polymyxin, and bacitracin topical medication prescribed?
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and b...
[Read More]

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Triple Antibiotic Product Label Images

Triple Antibiotic 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 - Purpose

Active ingredient (in each gram)  PurposeBacitracin Zinc 400 UnitsFirst Aid AntibioticNeomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)First Aid AntibioticPolymyxin B Sulfate 5000 UnitsFirst Aid Antibiotic

• Uses

  • First aid to help prevent infection in minor:cutsscrapesburns

• Warnings

For external use only

• Do Not Use

  • In the eyesif you are allergic to any of the ingredientsover large areas of the body

• Ask A Doctor Before Use If You Have

  • Animal bitesSerious burnsDeep or puncture wounds

• Stop Use And Ask A Doctor If

  • You need to use longer than 1 weekCondition persists or gets worseRash 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 immediately.

• Directions

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

• Other Information

  • Store at controlled room temperature 15°-30° C (59°-86° F)

• Inactive Ingredients

White Petrolatum

Other

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone, Gandhidham-370 230, Gujrat. India

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