NDC 0574-4021 Polycin

Bacitracin Zinc And Polymyxin B Sulfates

NDC Product Code 0574-4021

NDC CODE: 0574-4021

Proprietary Name: Polycin 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 And Polymyxin B Sulfates 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat eye infections. This product contains bacitracin and polymyxin, antibiotics that work by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections (e.g., infections caused by viruses, fungi, mycobacteria). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

NDC Code Structure

  • 0574 - Paddock Laboratories, Llc

NDC 0574-4021-35

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

Price per Unit: $3.31412 per GM

NDC Product Information

Polycin with NDC 0574-4021 is a a human prescription drug product labeled by Paddock Laboratories, Llc. The generic name of Polycin is bacitracin zinc and polymyxin b sulfates. The product's dosage form is ointment and is administered via ophthalmic form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 213621 and 308511.

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 Prescription 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.

Polycin 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)
  • MINERAL OIL (UNII: T5L8T28FGP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Cell Wall Synthesis & Repair - [PE] (Physiologic Effect)
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Paddock Laboratories, Llc
Labeler Code: 0574
FDA Application Number: ANDA065022 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 11-12-2014 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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Polycin 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

Description:

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: bacitracin zinc equivalent to 500 bacitracin units, polymyxin B sulfate equivalent to 10,000 polymyxin B units, mineral oil, and white petrolatum.Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformisgroup of Bacillus subtilisvar Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is:Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa(Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Clinical Pharmacology:

A wide range of antibacterial action is provided by the overlapping spectra of bacitracin and polymyxin B sulfate. Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis. Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Microbiology:

Bacitracin zinc and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacterspecies, Neisseria species and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratiamarcescens.

Indications And Usage:

Polycin® Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

Contraindications:

Polycin® Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings:

NOT FOR INJECTION INTO THE EYE. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. Topical antibiotics may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply, as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

General:

As with other antibiotic preparations, prolonged use of Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment may result in overgrowth of non susceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated. Bacterial resistance to Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment may also develop. If purulent discharge, inflammation, or pain become aggravated, the patient should discontinue use of the medication and consult a physician.There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom has a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information For Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients. Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size, or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Pregnancy Category C.

Animal reproduction studies have not been conducted with polymyxin B sulfate or bacitracin. It is also not known whether Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions:

Adverse reactions have occurred with the anti-infective components Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported.To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration:

May be applied every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

How Supplied:

Polycin® Ophthalmic Ointment is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip.NDC 0574-4021-35Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Polycin® is a Registered Trademark of Perrigo CompanyManufactured For Perrigo, Minneapolis, MN 55427R1113Ini11136U200 RC J1Rev 12-13 A

Package/Label Display Panel - Label

Rx OnlyNDC 0574-4021-35STERILEPolycin®bacitracin zinc and polymyxin B sulfateOphthalmic Ointment USPNET WT 3.5 g(1/8 oz)

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