NDC 69396-044 Tripleantibioticointmentandpainrelief

Family Wellness Bacitracin,neomycin,polymyxinb,pramoxine

NDC Product Code 69396-044

NDC Code: 69396-044

Proprietary Name: Tripleantibioticointmentandpainrelief 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: Family Wellness Bacitracin,neomycin,polymyxinb,pramoxine 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

  • 69396 - Trifecta Pharmaceutical Usa Llc
    • 69396-044 - Tripleantibioticointmentandpainrelief

NDC 69396-044-01

Package Description: 1 TUBE in 1 BOX > 28.4 g in 1 TUBE

NDC Product Information

Tripleantibioticointmentandpainrelief with NDC 69396-044 is a a human over the counter drug product labeled by Trifecta Pharmaceutical Usa Llc. The generic name of Tripleantibioticointmentandpainrelief is family wellness bacitracin,neomycin,polymyxinb,pramoxine. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Trifecta Pharmaceutical Usa 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.

Tripleantibioticointmentandpainrelief 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 500 [USP'U]/100g
  • NEOMYCIN SULFATE 3.5 mg/100g
  • PRAMOXINE HYDROCHLORIDE 10 mg/100g
  • POLYMYXIN B SULFATE 10000 [USP'U]/100g

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: Trifecta Pharmaceutical Usa Llc
Labeler Code: 69396
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: 08-30-2019 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: 12-31-2020 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.

Tripleantibioticointmentandpainrelief 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 500 Units

Neomycin 3.5mg

Polymyxin B 10,000 Units

Pramoxine HCL 10mg

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

External Analgesic

Uses

  • First Aid to help prevent infection in minor:CutsScrapesBurns

Warnings

  • For external use only. Do not use:In eyesOver large areas of the bodyIf you are allergic to any of the ingredients

Ask A Doctor Before Use

  • Ask Doctor before use if you have:Deep or puncture wounsAnimal bitesSerious burns

Stop Use And Ask A Doctor If:

  • Condition persists or gets worseYou need to use longer than 1 weekA rash or other allergic reaction develops

Keep Out Of Reach Of Children

If Swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Clean the affected area and dry thoroughlyApply 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

  • To Open: Unscrew cap, pull tab to remove foil sealStore at 20° to 25°C (68° to 77°F)See carton or tube crimp for lot number and expiration date

Inactive Ingredient:

Petrolatum

Questions?

Call 1-888-296-9067Weekdays 9AM - 4PM ESTDISTRIBUTED BY: MIDWOOD BRANDS, LLC.500 Volvo Parkway, Chesapeake, VA. 23320NOT SATISFIED?Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® Plus Pain Relief.

* Please review the disclaimer below.