Neosporin: Package Insert / Prescribing Information - Drugs.com (2023)

Package insert / prescribing information
Generic name: neomycin sulfate, polymyxin B sulfate and bacitracin zinc
Dosage form: Ophthalmic Ointment
Drug class: Ophthalmic anti-infectives

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

On This Page
  • Description
  • Clinical Pharmacology
  • Indications and Usage
  • Contraindications
  • Warnings
  • Precautions
  • Patient Counseling Information
  • Adverse Reactions/Side Effects
  • Dosage and Administration
  • How Supplied/Storage and Handling

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Description

Neosporin OPHTHALMIC OINTMENT (neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment) is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, and white petrolatum, q.s.

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 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Neosporin: Package Insert / Prescribing Information - Drugs.com (1)

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 mg, calculated on an anhydrous basis. The structural formulae are:

Neosporin: Package Insert / Prescribing Information - Drugs.com (2)

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Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

Neosporin: Package Insert / Prescribing Information - Drugs.com (3)

Clinical Pharmacology

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

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.

Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

Microbiology: Neomycin sulfate, polymyxin B sulfate, and bacitracin zinc 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.

Indications and Usage

Neosporin Ophthalmic Ointment 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.

Contraindications

Neosporin Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

NOT FOR INJECTION INTO THE EYE. Neosporin OPHTHALMIC OINTMENT should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

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. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

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Precautions

General

As with other antibiotic preparations, prolonged use of Neosporin Ophthalmic Ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to Neosporin Ophthalmic Ointment may also develop. If purulent discharge, inflammation, or pain become aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitrowith neomycin increased the frequency of chromosome aberrations at the highest concentration (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Pregnancy

Teratogenic Effects

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Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin, It is also not known whether Neosporin Ophthalmic Ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Neosporin Ophthalmic Ointment should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neosporin Ophthalmic Ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

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

Local irritation on instillation has also been reported.

Dosage and Administration

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

How Supplied

Tube of 1/8 oz (3.5 g) with ophthalmic tip (NDC 0081-0732-86).

Caution: Federal law prohibits dispensing without a prescription.

Store at 15° to 25°C (59° to 77°F).

Manufactured by:

Burroughs Wellcome Inc.

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Kirkland; Que., Canada H9H 4J4 for

BURROUGHS WELLCOME CO.

Research Triangle Park, NC 27709

Neosporin
neomycin sulfate, polymyxin b sulfate and bacitracin zinc ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0081-0732
Route of AdministrationOPHTHALMICDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
neomycin sulfate (neomycin)neomycin3.5 ug in 1 g
polymyxin B sulfate (polymyxin B)polymyxin B10000 in 1 g
bacitracin zinc (bacitracin)bacitracin400 in 1 g
Inactive Ingredients
Ingredient NameStrength
white petrolatum
Packaging
#Item CodePackage Description
1NDC:0081-0732-863.5 g (3.5 GRAM) in 1 TUBE

Labeler - Burroughs Wellcome Inc.

Burroughs Wellcome Inc.

Frequently asked questions

  • Can you buy antibiotics over the counter?

More about bacitracin / neomycin / polymyxin b ophthalmic

  • Reviews (2)
  • Latest FDA alerts (1)
  • Side effects
  • Dosage information
  • During pregnancy
  • Drug class: ophthalmic anti-infectives
  • En español

Patient resources

  • Drug Information
  • Neomycin, polymyxin b, and bacitracin Ophthalmic (Advanced Reading)

Professional resources

  • Prescribing Information

Other brands

Neo-Polycin

Related treatment guides

  • Blepharitis
  • Blepharoconjunctivitis
  • Conjunctivitis, Bacterial
  • Hordeolum
  • Keratitis
  • Keratoconjunctivitis

Medical Disclaimer

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FAQs

What drug class is Neosporin? ›

Neosporin Ophthalmic Ointment belongs to a class of drugs called Antibiotics, Ophthalmic Combos.

What is Neosporin generic name? ›

Neomycin/polymyxin B/bacitracin/pramoxine is available under the following different brand names: Neosporin Plus Pain Relief Ointment and TriBiozene Ointment.

What are the side effects of Neosporin? ›

Burning, redness, or irritation of the skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects.

When not to use Neosporin? ›

Do not apply the ointment over large skin areas. Do not use on a deep cut, an animal bite, or a serious burn. Contact your doctor for instructions on how to treat these more severe skin injuries. This medication can be applied up to 3 times each day, or as directed on the medicine label.

Is Neosporin a prescription drug? ›

This medication is used to prevent and treat minor skin infections caused by small cuts, scrapes, or burns. It is available without a prescription for self-medication.Do not use this product over large areas of the body.

What is prescription strength Neosporin called? ›

Bactroban (mupirocin) is a prescription antibacterial ointment that can kill more types of bacteria than the OTC ointments. There are also several other prescription ointments used for bacterial skin infections. Your healthcare provider can advise you on which antibacterial ointment would be best for your condition.

What are the 3 ingredients of Neosporin? ›

Introducing a no sting formula free of preservatives, parabens and neomycin: 3 effective ingredients: bacitracin zine, polymyxin B sulfate & petrolatum.

What bacteria does Neosporin treat? ›

Neomycin and polymyxin B are primarily active against gram-negative, aerobic bacteria, while bacitracin is effective against gram-positive bacteria.

What is Neosporin best for? ›

Neosporin, sometimes known as "triple antibiotic," is a combination antibiotic ointment used to help prevent skin infections in minor cuts, scrapes, and burns. It's not meant to treat animal bites, serious burns, or deep puncture wounds - those might require medical attention.

Why do doctors not want you to use Neosporin? ›

Neomycin frequently causes allergic reactions of the skin called contact dermatitis. It can cause the skin to become red, scaly, and itchy. The more Neosporin you use, the worse the skin reaction gets. Neomycin is such a common allergen that it was named Allergen of the Year in 2010.

Can you use Neosporin too often? ›

Neosporin is no longer recommended because it contains neomycin, which is a common allergen. It frequently causes allergic contact dermatitis with red, itchy, and scaly skin. The skin reaction gets worse the more Neosporin you use.

Can Neosporin be used on private parts? ›

Neosporin isn't recommended as a topical antibiotic due to its risk of allergic reaction. Only apply these ointments if the cuts are in the outer area around your vulva and its labia. Shop for Bacitracin and Aquaphor now.

Is Vaseline or Neosporin better for cuts? ›

They gave small skin wounds to human participants and applied Vaseline or Neosporin. The people who applied Vaseline healed faster than those who applied Neosporin to their wounds. This suggests that Neosporin kills the bacteria and makes the wounds heal slower, Garza said.

Is Vaseline better than antibiotic ointment? ›

Studies show that petroleum jelly is just as effective as an antibiotic ointment for non-infected wounds. Don't douse a minor wound with antiseptics like iodine or hydrogen peroxide. They're actually harmful to the skin and can delay healing.

Is it OK to put Neosporin on an open wound? ›

Antibiotic ointments (such as Neosporin) help wounds heal by keeping out infection and by keeping the wound clean and moist. If your child has stitches, your doctor will tell you whether you should use an antibiotic ointment. Most cuts and scrapes heal without antibiotic ointment.

Is Neosporin OTC or prescription? ›

Polysporin (bacitracin/polymyxin B), Neosporin (bacitracin/neomycin/polymyxin B), and bacitracin are all over-the-counter (OTC) antibiotic ointments that you can use to help treat or prevent infection for minor cuts or scrapes.

Is there a prescription antibiotic ointment? ›

Topical antibiotics are antibiotic medications used to treat or prevent bacterial infections on the skin or mucous membranes. They are available both over-the-counter and with a prescription.

What is the difference between Neosporin and Neosporin? ›

Official answer. Neosporin contains neomycin which is not present in polysporin. Polysporin is the brand name for a product containing bacitracin zinc and polymyxin B sulfate. Neosporin is the brand name for a product containing bacitracin zinc, polymyxin B sulfate and neomycin sulfate.

Do dermatologists recommend Neosporin? ›

Neosporin is the one that most people have heard of, it has great brand-name recognition. However, most dermatologists do not recommend using Neosporin. Neosporin contains a mixture of 3 topical antibacterial medications: Neomycin, polymixin, and bacitracin.

What antibiotic cream is good for wound healing? ›

Bacitracin and Neosporin are both OTC topical antibiotics used as first aid to help prevent infection from minor abrasions, wounds, and burns.

What pain killer is in Neosporin? ›

Neosporin Plus Pain Relief ointment is a combination ointment applied on the skin that contains three antibiotics (bacitracin, neomycin, and polymyxin B) and a medication for pain (pramoxine). It's used to prevent skin infections in minor cuts and burns, and to relieve pain temporarily for people 2 years and older.

What class of drug is neomycin? ›

Neomycin belongs to a group of antibiotics known as aminoglycosides. Like others in the aminoglycoside family, neomycin works by inhibiting bacterial protein synthesis leading to its bactericidal effect.

What drug group is neomycin? ›

Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.

What type of drug is neomycin? ›

Neomycin, an antibiotic, is used to prevent or treat skin infections caused by bacteria. It is not effective against fungal or viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What drug class is bacitracin? ›

Bacitracin is in a class of medications called antibiotics. Bacitracin works by stopping the growth of bacteria.

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