NDC 59961-153 Travel Savvy Triple Antibiotic

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

NDC Product Code 59961-153

NDC CODE: 59961-153

Proprietary Name: Travel Savvy Triple Antibiotic What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 59961 - Bellegrove Medical Supply, Inc.

NDC 59961-153-45

Package Description: 450 PACKET in 1 BOX > .5 g in 1 PACKET

NDC Product Information

Travel Savvy Triple Antibiotic with NDC 59961-153 is a a human over the counter drug product labeled by Bellegrove Medical Supply, Inc.. The generic name of Travel Savvy Triple Antibiotic is bacitracin zinc, neomycin sulfate, polymyxin b sulfate. The product's dosage form is ointment and is administered via topical form.

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.

Travel Savvy 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.


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: Bellegrove Medical Supply, Inc.
Labeler Code: 59961
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: 06-04-2018 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: 12-31-2022 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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Travel Savvy Triple Antibiotic Product Label Images

Travel Savvy 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

Active Ingredients

Bacitracin Zinc (400 units of Bacitracin)Neomycin sulfate 5 mg

(equivalent to 3.5 mg of Neomycin base)
Polymyxin B sulfate 5000 units

Purpose

First aid antibiotic

Uses

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

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 doctorinternally

Ask A Doctor Before Use

  • In case of deep puncture wounds, animal bites or serious burns

Stop Use And Ask A Doctor If

  • The condition persists or gets worsea rash or other allergic reaction develops

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions

  • Clean 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

Other Information

  • Store at room temperature 15° to 25°C (59° to 77°F) (do not freeze)do not use any open or torn packets

Inactive Ingredients

Petrolatum

Travel Savvy Triple Antibiotic Label

Travel™SavvyBTavelSavvy.comFirst AidTripleAntibioticOintmentBacitracin Zinc • Neomycin SulfatePolymycin-B SulfateHelps preventinfection inminor cuts, scrapesand burns0.5g (1/57 oz)Packets450 Per Box

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