Drug Catalog - Product Detail
NEOMYCIN/BACITRACIN/POLYMYXIN-B OPHTH OINT USP OINT 3.5/400/5GM 3.5GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00574-4250-35 | PADAGIS | 3 | 3.5-400-10000 | OINTMENT |
PACKAGE FILES
Generic Name
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
Substance Name
BACITRACIN ZINC
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA060764
Description
DESCRIPTION: Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is a sterile antimicrobial ointment for topical ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and bacitracin zinc equivalent to 400 bacitracin units in a white petrolatum and mineral oil base. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae ). It has a potency equivalent of not less than 600 micrograms of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are: 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 per mg, calculated on an anhydrous basis. The structural formulae are: 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 is: Chemical Structure 1 Chemical Structure 2 Chemical Structure 3
How Supplied
HOW SUPPLIED: Neo-Polycin® Ophthalmic Ointment is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. NDC 0574- 4250 -35 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Neo-Polycin is a Registered Trademark of Perrigo Company FOR TOPICAL OPHTHALMIC USE
Indications & Usage
INDICATIONS AND USAGE: Neo-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 and Administration
DOSAGE AND ADMINISTRATION Apply the ointment topically into the conjunctival sac of the affected eye(s) every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.