SPL Set ID: 691bc5ca-5d61-60c2-e053-2991aa0abb93

1 drug(s) with this SPL Set ID

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Neomycin Polymyxin B Sulfates and Dexamethasone NEOMYCIN SULFATE POLYMYXIN B SULFATE AND DEXAMETHASONE

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP is a multiple dose anti-infective steroid combination in a sterile suspension for topical application. The active ingredient, Dexamethasone, is represented by the following structural formula: C 22 H 29 FO 5 Mol. Wt. 392.47 Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. 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 to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formula 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 per milligram, calculated on an anhydrous basis. The structural formula is: Each mL contains: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg neomycin), Polymyxin B Sulfate equal to 10,000 polymyxin B units, Dexamethasone 1 mg (0.1%); INACTIVES: Sodium Chloride, Hypromellose, Polysorbate 20, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.004% Dexamethasone (structural formula) Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula)

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