Label: AK-POLY-BAC- ak-poly-bac ointment
- NDC Code(s): 61919-989-35
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 17478-238
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 10, 2016
If you are a consumer or patient please visit this version.
- DESCRIPTION SECTION
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:
Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.Close
- CLINICAL PHARMACOLOGY SECTION
Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.
Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.Close
- INDICATIONS & USAGE SECTION
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfateClose
- CONTRAINDICATIONS SECTION
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.Close
- WARNINGS SECTION
Ophthalmic ointments may retard corneal healing.Close
- PRECAUTIONS SECTION
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.Close
- DOSAGE & ADMINISTRATION SECTION
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.Close
- HOW SUPPLIED SECTION
Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
Principal Display Panel Text for Container Label:
NDC 17478-238-35 Akorn
brand of Bacitracin Zinc and Polymyxin B Sulfate
Ophthalmic Ointment USP
For Ophthalmic Use Only. Sterile
Rx only Net Wt. 3.5 g (1/8oz.)Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-989(NDC:17478-238) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-989-35 3.5 g in 1 CARTON; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064028 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-989)