Bacitracin Zinc And Polymyxin B Sulfate Ointment

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Bacitracin Zinc And Polymyxin B Sulfate Ointment Recall

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Side Effects & Adverse Reactions

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).

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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Uses

Bacitracin Zinc and Polymyxin B Sulfate 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.

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History

There is currently no drug history available for this drug.

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Other Information

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 licheniformis group of Bacillus subtilis var 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:

Sources

Bacitracin Zinc And Polymyxin B Sulfate Ointment Manufacturers

E. Fougera & Co., A Division Of Nycomed Us Inc.

Bacitracin Zinc And Polymyxin B Sulfate Ointment | E. Fougera & Co., A Division Of Nycomed Us Inc.

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Physicians Total Care, Inc.

Bacitracin Zinc And Polymyxin B Sulfate Ointment | Physicians Total Care, Inc.

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Rebel Distributors Corp.

Bacitracin Zinc And Polymyxin B Sulfate Ointment | Rebel Distributors Corp.

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
H.j. Harkins Company, Inc.

Bacitracin Zinc And Polymyxin B Sulfate Ointment | H.j. Harkins Company, Inc.

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

No Recall
Stat Rx Usa Llc

Bacitracin Zinc And Polymyxin B Sulfate Ointment | Stat Rx Usa Llc

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Rebel Distributors Corp

Bacitracin Zinc And Polymyxin B Sulfate Ointment | Rebel Distributors Corp

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

FOR OPHTHALMIC USE ONLY.

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Bacitracin Zinc And Polymyxin B Sulfate Ointment | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Bausch & Lomb Incorporated

Bacitracin Zinc And Polymyxin B Sulfate Ointment | Bausch & Lomb Incorporated

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

FOR OPHTHALMIC USE ONLY.

No Recall