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 ADDED: 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 Bl 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 Bacillusbrevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.

Microbiology: Neomycin sulfate, polymyxin B sulfate and gramicidin together are considered active against the following microorganisms:

Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

This product is contraindicated in those persons who have shown hypersensitivity to any of its components.

NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.

The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication.

Applications of products containing these ingredients should be avoided for the patient thereafter. (See PRECAUTIONS, General)

Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP NDC 21695-528-10 is supplied in a plastic squeeze bottle with a controlled drop tip in the following size:

10 mL .

Store between 15°– 30° C (59°– 86° F).

PROTECT FROM LIGHT.

KEEP OUT OF REACH OF CHILDREN.

STERILE OPHTHALMIC SOLUTION

Rx Only

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320