Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
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Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
DESCRIPTION SECTION
DESCRIPTION
Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is a sterile antimicrobial solution for ophthalmic use.
Each mL contains: Actives: neomycin sulfate, (equivalent to 1.75 mg neomycin base), polymyxin B sulfate equal to 10,000 polymyxin B units, gramicidin, 0.025 mg;Inactives: sodium chloride, alcohol (0.5%), Poloxamer 188, propylene glycol, purified water. Hydrochloric acid and/or ammonium hydroxide may be added to adjust pH (4.7-6.0).
**Preservative:**thimerosal 0.001%.
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 of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.
The structural formulae are:
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 milligram, calculated on an anhydrous basis. The structural formulae are:
Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:
