Drugplain

polycin 500 [USP'U]/g

bacitracin zinc and polymyxin b sulfates · OINTMENT · NuCare Pharmaceuticals,Inc.

3 Recalls on Record
Plain English

Polycin is a prescription antibiotic ointment applied to the eye that contains bacitracin zinc and polymyxin B sulfates to treat bacterial eye infections. It works by killing bacteria that cause conditions like conjunctivitis and other eye infections.

Key Facts

Brand Name
polycin
Generic Name
bacitracin zinc and polymyxin b sulfates
NDC Code (Product)
66267-925
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
500 [USP'U]/g
Dosage Form
OINTMENT
Route
OPHTHALMIC
Marketing Status
Application #
ANDA065022
Marketing Start
11/12/2014

Recall History

3 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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

Warnings

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 ).

Contraindications

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

Adverse Reactions

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.

Frequently Asked Questions

What is polycin used for?

Polycin is a prescription antibiotic ointment applied to the eye that contains bacitracin zinc and polymyxin B sulfates to treat bacterial eye infections. It works by killing bacteria that cause conditions like conjunctivitis and other eye infections.

Is polycin a controlled substance?

polycin is not classified as a controlled substance by the DEA.

What is the generic name for polycin?

The generic name for polycin is bacitracin zinc and polymyxin b sulfates. There are no other listed brand versions of bacitracin zinc and polymyxin b sulfates.

What is the NDC code for polycin 500 [USP'U]/g?

The NDC (National Drug Code) for polycin 500 [USP'U]/g is 66267-925, listed by NuCare Pharmaceuticals,Inc..

Product NDC

66267-925

Package NDC

66267-925-35

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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