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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 per mg. The structural formula for bacitracin A is:
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: ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum and Mineral Oil.
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INGREDIENTS AND APPEARANCE
BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-154(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 ZINC 500 in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 10000 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:42254-154-35 1 in 1 CARTON 1 3.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064046 04/25/2008 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK