NDC 55670-600 Triple Antibiotic

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

NDC Product Code 55670-600

NDC 55670-600-01

Package Description: 144 PACKET in 1 BOX > 1 g in 1 PACKET

NDC Product Information

Triple Antibiotic with NDC 55670-600 is a a human over the counter drug product labeled by Moore Medical Llc. The generic name of Triple Antibiotic is bacitracin zinc, neomycin sulfate, polymyxin b sulfate. 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: 204602.

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.


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: Moore Medical Llc
Labeler Code: 55670
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: 07-11-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-15-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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 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 Ingredient

Bacitracin Zinc 400 units
Neomycin sulfate 5 mg (equivalent to 3.5 mg of neomycin base)
Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotics

Uses

  • First aid to help prevent infection in:
  • Minor cuts
  • Scrapes
  • Burns

Warnings

For external use only

Do Not Use:

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
  • For more than 1 week unless directed by a doctor

Ask A Doctor Before Use:

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

Stop Use And Ask A Doctor If:

  • The condition persists or gets worse
  • A rash or allergic reaction develops

Keep This And All Drugs Out Of The Reach Of Children.

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

Directions

  • Clean the 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 15° to 25°C (59° to 77°F)
  • Tamper Evident Sealed Packets
  • Do Not Use any Opened or Torn Packets

Inactive Ingredients

Petrolatum

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