Label: BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment
- NDC Code(s): 72189-017-35
- Packager: Direct_Rx
- This is a repackaged label.
- Source NDC Code(s): 24208-555
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 24, 2019
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- SPL UNCLASSIFIED SECTION
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:
[Bacitracin A (Strucural Formula)]
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/mg, calculated on an anhydrous basis. The structural formulae are:
[Polymyxin B Sulfate (Structural Formula)]
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.
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is available in tubes with an ophthalmic tip applicator in the following size:
3.5 g tube
DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.
Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED.
Keep out of reach of children
Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
© Bausch & Lomb Incorporated
Revised: November 2017
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72189-017(NDC:24208-555) 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 PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72189-017-35 3.5 g in 1 BOTTLE; Type 0: Not a Combination Product 07/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064046 07/24/2019 Labeler - Direct_Rx (079254320) Registrant - Direct_Rx (079254320) Establishment Name Address ID/FEI Business Operations Direct_Rx 079254320 repack(72189-017)