Is bacitracin FDA-approved, and what does the research show?

What is bacitracin?

Bacitracin is an antibiotic, a medicine that kills or stops bacteria, and not a peptide for wellness, weight or performance. It is a polypeptide, a chain of amino acids, and its molecule is cyclic, closed in a loop ¹. The drug is a mixture of several related bacitracins, mainly bacitracin A ¹, ³.

It is made by growing a bacterium of the Bacillus subtilis group, and it is named after the patient whose wound yielded the strain ³, ¹¹. FDA approved bacitracin for injection on July 29, 1948 ⁸. It is sold as a plain first-aid ointment ¹² and, under the FDA rule explained below, in combination with neomycin and polymyxin B, two other antibiotics ².

Is bacitracin FDA-approved?

Yes, for prescription eye ointments that combine it with other antibiotics. First-aid ointments are sold under an FDA rule without an approval, and the injection's approval is gone.

First, the eye ointments. Drugs@FDA is FDA's database of approved applications. It lists 38 applications with bacitracin as an active ingredient as of November 6, 2026, the date of its data ⁴. Four carry the marketing status "Prescription" ⁴. All four are eye ointments that combine bacitracin zinc with polymyxin B; three also contain neomycin, and one adds the steroid hydrocortisone ⁴.

The oldest, Lumi-Sporyn, was approved on May 10, 1971, and Bausch & Lomb's bacitracin zinc and polymyxin B sulfate ointment on January 26, 1995 ⁴. The Bausch & Lomb label indicates it "for the treatment of superficial ocular infections involving the conjunctiva and/or cornea," the eye's surface, "caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate" ³. Every single-ingredient bacitracin application in the database, for the eye, the skin, pharmacy compounding or injection, is listed as "Discontinued" ⁴.

Second, the over-the-counter ointments. FDA's page describes "two regulatory pathways for nonprescription drugs to come to market: the drug application process and the OTC drug monograph process" ⁵.

The first aid antibiotic monograph, in Title 21 of the Code of Federal Regulations, names bacitracin and bacitracin zinc ointments among its active ingredients ². Such a product "is generally recognized as safe and effective and is not misbranded if it meets each of the conditions" of the rule ². The rule defines a first aid antibiotic as "an antibiotic-containing drug product applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns" ². A current bacitracin label on DailyMed, the National Library of Medicine's label database, carries exactly that use and is filed as an OTC monograph drug ¹².

Third, the injection, which is gone. On January 31, 2020, FDA "requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market" ⁶. The drug was approved only "to treat infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci" ⁶. Clinicians no longer used it for that, FDA wrote, because other approved treatments without its serious risks exist ⁶. FDA's advisory committee, a panel of outside experts, had voted in April 2019, "almost unanimously, with one abstention, that the risks outweigh the benefits" ⁶.

FDA withdrew the approval of five applications on March 12, 2021, and a sixth on July 11, 2022 ⁷, ⁸. It wrote that it "has withdrawn approval of all ANDAs for bacitracin for injection," an ANDA being an application for a generic drug ⁸. In September 2022 it determined that the injection "was withdrawn from sale for reasons of safety or effectiveness," so no generic copy can be approved ⁸. FDA said in 2020 that its request "does not impact approved topical or ophthalmic drugs that contain bacitracin" ⁶.

See the FDA status of every peptide, updated weekly.

How does bacitracin work?

Bacitracin stops bacteria from building their cell wall, the rigid outer layer a bacterium needs to survive ¹, ¹³. It first binds a metal ion such as zinc ¹. That complex then binds a carrier molecule, C55-isoprenyl pyrophosphate ¹, which the bacterium uses to ferry wall building blocks ¹¹. With the carrier blocked, the wall cannot be completed ¹.

Gram-positive bacteria are one of the two broad groups of bacteria; the eye-ointment label says bacitracin "is active against most gram-positive bacilli and cocci including hemolytic streptococci" ³. Applied to the skin, it is "not substantially absorbed from intact or denuded skin, wounds, or mucous membranes," one prescribing reference says ¹³. A clinical reference differs: it says bacitracin is "readily absorbed through denuded, burned, or granulated skin" ¹¹. This account comes from DrugBank, a drug database, a prescribing reference, a clinical reference and an FDA-approved label, not from trials of the mechanism in people ¹, ¹¹, ¹³, ³.

What does the research show?

The evidence for bacitracin is an FDA-approved use, plus randomized trials of the ointment for preventing wound infection ⁴, ⁹, ¹⁰. The question those trials asked is whether an antibiotic ointment beats plain petrolatum, petroleum jelly ⁹, ¹⁰.

Studied in people after skin surgery: a randomized, double-blind trial at Walter Reed Army Medical Center was published in September 1996 ⁹. It enrolled 922 patients with 1,249 wounds after dermatologic surgery ⁹. Of 440 evaluable patients on white petrolatum, 9 (2.0 percent) developed an infection, against 4 (0.9 percent) of 444 on bacitracin ointment; these counts are patients, not wounds ⁹. The difference was not statistically significant, small enough to be chance ⁹.

All 8 infections with Staphylococcus aureus, a common skin bacterium, were in the petrolatum group ⁹. No patient on petrolatum developed allergic contact dermatitis, a rash from an allergy to something touching the skin, against 4 (0.9 percent) on bacitracin ⁹. Healing did not differ at day 1, day 7 or day 28 ⁹. The authors concluded that white petrolatum "possesses an equally low infection rate and minimal risk for induction of allergy" ⁹.

Studied in people after emergency-room wound repair: a randomized, double-blind trial at a military hospital was published in January 1995 ¹⁰. It compared four topical treatments on wounds repaired in the emergency room ¹⁰. Infections occurred in 6 of 109 in the bacitracin zinc group (5.5 percent) and 5 of 110 on a neomycin, bacitracin and polymyxin B combination (4.5 percent) ¹⁰. They occurred in 12 of 99 on silver sulfadiazine (12.1 percent) and 19 of 108 on petrolatum (17.6 percent) ¹⁰. The two antibiotic ointments had the lowest infection rates, and the difference across the four arms was statistically significant ¹⁰.

A Cochrane review is an independent systematic review of trials. One published online in November 2016 included 14 randomized or quasi-randomized trials of topical antibiotics on surgical wounds closed by stitches or similar ¹⁴. They held 6,466 participants ¹⁴.

Against no antibiotic, topical antibiotics "probably reduce" the risk of surgical site infection, on moderate-quality evidence ¹⁴. The risk ratio, the infection rate with an antibiotic divided by the rate without, was 0.61 ¹⁴. Its 95 percent confidence interval, the range the true figure likely sits in, was 0.42 to 0.87 ¹⁴. That is about 20 fewer infections per 1,000 patients ¹⁴. That pooled result is for topical antibiotics as a class; the review's abstract gives no bacitracin-only figure ¹⁴.

Whether they raise the risk of allergic contact dermatitis was "unclear," on very low-quality evidence, and the review could draw no conclusion about antibiotic resistance ¹⁴. The review's only comparison of the three-antibiotic combination with bacitracin zinc alone is a four-arm trial, 219 participants in those two arms ¹⁴. It found no clear difference, on low-quality evidence ¹⁴. Those arms match the emergency-room trial above ¹⁰, ¹⁴. In the review's words, "the relative effects of different topical antibiotics are unclear" ¹⁴.

The injection's record runs the other way: FDA's advisory committees twice judged against it ⁸. FDA wrote in 2022 that in 1984 its advisory committee "concluded that intramuscular administration of bacitracin was not safe and effective"; the 2019 vote is above ⁸. No trial of bacitracin for weight, muscle, skin aging or any wellness use was found among this page's sources as of November 10, 2026 ¹, ¹¹, ¹³, ⁹, ¹⁰, ¹⁴.

What are the side effects?

Allergy leads. The over-the-counter label's warnings follow the monograph's warnings ¹², ². The label warns users not to use it if allergic to any ingredient ¹². It says to stop and ask a doctor if a rash or other allergic reaction develops, or if the condition persists or worsens ¹².

It says the product is for external use only, not for the eyes or large areas of the body ¹². A doctor should be asked first about deep or puncture wounds, animal bites or serious burns ¹². It also warns against use beyond one week without a doctor's word ¹².

A prescribing reference lists rash, itching and pain, with hypersensitivity reactions, allergic reactions, as rare, and says topical anti-infectives "are known contact sensitizers," substances that cause contact allergy ¹³. It adds that people sensitive to bacitracin "may also have cross-sensitivity to polymyxin B" ¹³. "Serious hypersensitivity reactions, including anaphylaxis," a severe whole-body allergic reaction, have been "reported rarely following topical application to skin" ¹³. The journal of the American Contact Dermatitis Society titled a March 2003 article "Bacitracin: allergen of the year" ¹⁵.

Patch tests are skin tests for contact allergy. The North American Contact Dermatitis Group patch-tested 4,308 patients in 2009 to 2010 ¹⁶. A 1998 case report in the Journal of Allergy and Clinical Immunology was titled "Near-fatal anaphylaxis to topical bacitracin ointment" ¹⁷.

The injection's harms were the reason it left the market. FDA wrote that other treatments "do not have the same serious risks, including nephrotoxicity (harm to the kidneys), anaphylactic reactions and the need for repeated intramuscular injections" ⁶, ⁷. The prescription eye ointment is "contraindicated in those individuals who have shown hypersensitivity to any of its components," meaning they must not use it ³. Its label warns that "ophthalmic ointments may retard corneal healing" ³. The prescribing reference also cautions that prolonged use of topical anti-infectives "may promote bacterial resistance" and that "overgrowth of nonsusceptible organisms, including fungi, may occur" ¹³.

In sport

The World Anti-Doping Agency, WADA, does not name bacitracin on its 2026 Prohibited List, and the list names no class of antibiotics ¹⁸. The list sets which substances are prohibited in sport ¹⁸.

What JumpstartMD offers

JumpstartMD does not prescribe bacitracin. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.