Drug Catalog - Product Detail
BACITRACIN/ZINC/POLY B OPTH OINT OINT 500/10GM 3.5GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 24208-0555-55 | BAUSCH HEALTH | 3 | 500-10000UNIT/GM | OINTMENT |
PACKAGE FILES
Generic Name
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Substance Name
BACITRACIN ZINC
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA064046
Description
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
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 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) do not use
Indications & Usage
INDICATIONS AND USAGE 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
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