Bacitracin Zinc and Polymyxin B Sulfate
Ointment · Ophthalmic
Uses
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.
Dosage and administration
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection. FOR OPHTHALMIC USE ONLY
Contraindications
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings
Ophthalmic ointments may retard corneal healing.
Side effects
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Description
Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is a sterile antimicrobial ointment formulated for ophthalmic use. 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/mg. The structural formula for bacitracin A is: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , 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/mg, calculated on an anhydrous basis. The structural formulae are: Each gram contains: Actives: bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units; Inactives: mineral oil and white petrolatum. bacitracinchemstructure polychemstructure
How supplied
Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is available in tubes with an ophthalmic tip applicator in the following size: NDC 24208-555-55 - 3.5 g tube do not use Storage: Store between 15°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: January 2023 9130705 (Folded) 9130605 (Flat)
Storage
Storage: Store between 15°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: January 2023 9130705 (Folded) 9130605 (Flat)
Label text from the FDA structured product label by Bausch & Lomb Incorporated (revised Oct 18, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Bacitracin Zinc in 4 products
- Polymyxin B Sulfate in 4 products
Bacitracin Zinc and Polymyxin B Sulfate NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-3274 | Bacitracin Zinc 500 [USP'U]/g; Polymyxin B Sulfate 10000 [USP'U]/g Ointment | A-S Medication Solutions | ANDA |
| 50090-7189 | Bacitracin Zinc 500 [USP'U]/g; Polymyxin B Sulfate 10000 [USP'U]/g Ointment | A-S Medication Solutions | ANDA |
| 24208-555 | Bacitracin Zinc 500 [USP'U]/g; Polymyxin B Sulfate 10000 [USP'U]/g Ointment | Bausch & Lomb Incorporated | ANDA |
| 68071-5267 | Bacitracin Zinc 500 [USP'U]/g; Polymyxin B Sulfate 10000 [USP'U]/g Ointment | NuCare Pharmaceuticals,Inc. | ANDA |
Frequently asked questions
What is Bacitracin Zinc and Polymyxin B Sulfate used for?
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.
What are the side effects of Bacitracin Zinc and Polymyxin B Sulfate?
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See the full label for the complete list.
Who makes Bacitracin Zinc and Polymyxin B Sulfate?
Bacitracin Zinc and Polymyxin B Sulfate is listed by 3 labelers in the FDA NDC directory, including A-S Medication Solutions, Bausch & Lomb Incorporated, NuCare Pharmaceuticals,Inc..