Mediclarum
Medicine guide

Neomycin and Polymyxin B Sulfates and Dexamethasone

3.5 mg/g + 10000 [USP'U]/g + 1 mg/g · Ointment

  • Prescription only
  • Aminoglycoside Antibacterial
Made by
Proficient Rx LP

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-05-01

What it is

Aminoglycoside Antibacterial

Used for
  • For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Do not take it if

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea and conjunctiva.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
4other products contain Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

The particular anti-infective drugs in this product is active against the following common bacterial eye pathogens:

  • For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
  • Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain cases of infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
  • They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation or thermal burns; or penetration of foreign bodies.
  • The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
  • Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species , Pseudomonas aeruginosa .
  • This product does not provide adequate coverage against Serratia marcescens, and Streptococci, including Streptococcus pneumoniae .

From the official label · 2023-05-01 · DailyMed

How it works

From this product’s own US prescribing label.

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow the healing.

Since corticoids may inhibit the body's defense mechanism against infections, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-05-01

Do not take it if

  • Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea and conjunctiva.
  • Mycobacterial infection of the eye.
  • Fungal diseases of ocular structures.
  • Hypersensitivity to a component of the medication.
  • (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Apply a small amount into the conjunctival sac(s) up to three or four times daily, or may be used adjunctively with Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension at bedtime.
  • How to apply Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment: 1.
  • Tilt your head back. 2.
  • Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3.
  • Place a small amount (about 1/2 inch) of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment in the "V" pocket.
  • Do not let the tip of the tube touch your eye. 4.
  • Look downward before closing your eye.
  • Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • NOT FOR INJECTION.
  • Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
  • Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections.
  • In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
  • In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
  • If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
  • Products containing neomycin sulfate may cause cutaneous sensitization.
  • Employment of steroid medication in the treatment of herpes simplex requires great caution.
  • General The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.
  • Information for Patients:
  • Pregnancy: Pregnancy Category C.
  • Nursing Mothers:
  • Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
  • General The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Pregnancy Category C.
  • Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.
  • In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate.
  • In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.
  • There are no adequate or well-controlled studies in pregnant women.
  • Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
  • Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
  • Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
  • It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
  • Because many drugs are excreted in human milk, caution should be exercised when Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Side effects

  • Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.
  • Exact incidence figures are not available since no denominator of treated patients is available.
  • Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations.
  • The reactions due to the steroid component are:
  • elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
  • Secondary Infection:
  • The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.
  • Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.
  • The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
  • Secondary bacterial ocular infection following suppression of host responses also occurs.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Do not touch tube tip to any surface, as this may contaminate the contents.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is supplied in an ophthalmic tube in the following size:
  • 3.5 gram tube – NDC 63187-669-35 Storage:
  • Store between 15°-25° C (59°-77° F).
  • KEEP OUT OF REACH OF CHILDREN.
  • DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.
  • FOR OPHTHALMIC USE ONLY.
  • Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeled by:
  • Proficient Rx LP Thousand Oaks, CA 91320 9114002 (Folded) 9114102 (Flat)

Quoted from the official label, section “How Supplied”.

How to store it

  • Store between 15°-25° C (59°-77° F).
  • KEEP OUT OF REACH OF CHILDREN.
  • DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.
  • FOR OPHTHALMIC USE ONLY.
  • Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeled by:
  • Proficient Rx LP Thousand Oaks, CA 91320 9114002 (Folded) 9114102 (Flat)

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is a multiple dose anti-infective steroid combination in a sterile ointment 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 formulae are:
  • 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 formulae are:
  • Each Gram 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: White Petrolatum, Lanolin, Mineral Oil.
  • PRESERVATIVES ADDED: Methylparaben 0.05%, Propylparaben 0.01%.
  • Neomycin Sulfate (structural formula) Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula)

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (5)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 5 of 5

Details

Made byProficient Rx LP
Active substanceNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
Used inAntibiotics, antivirals and antifungals taken into the body
Strength3.5 mg/g + 10000 [USP'U]/g + 1 mg/g
FormOintment
RouteOphthalmic
Packs1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
NDC63187-669

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

13 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Neomycin and Polymyxin B Sulfates and Dexamethasone3.5 mg/g + 10000 [USP'U]/g + 1 mg/gPrescription onlyOintment Bausch & Lomb Incorporated · Neomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone3.5 mg/g + 10000 [USP'U]/g + 1 mg/gPrescription onlyOintment A-S Medication Solutions · Neomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone3.5 mg/g + 10000 [USP'U]/g + 1 mg/gPrescription onlyOintment NuCare Pharmaceuticals,Inc. · Neomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone3.5 mg/g + 10000 [USP'U]/g + 1 mg/gPrescription onlyOintment Preferred Pharmaceuticals Inc. · Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone

See every product with Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone