SPL Set ID: 39dfffb0-612a-48f3-8db5-1a59899b91e9

1 drug(s) with this SPL Set ID

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Diclofenac Sodium DICLOFENAC SODIUM
BAUSCH & LOMB INCORPORATED FDA Rx Only

Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C 14 H 10 Cl 2 NO 2 Na. The structural formula of diclofenac sodium is: Diclofenac sodium ophthalmic solution is available as a sterile solution, which contains diclofenac sodium 0.1% (1 mg/mL). Inactive Ingredients: boric acid, edetate disodium (1 mg/mL), polyoxyl 35 castor oil, purified water, sorbic acid (2 mg/mL), and tromethamine. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil. Diclofenac Sodium (structural formula)

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