Over the Counter Drug Options for Cuts, Scrapes and Burns : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

About 1 in 20 people is allergic to neomycin, according to an article in the August 1995 Harvard Health Letter. If a reaction such as redness, itching or burning occurs, the article advises, "Stop using the preparation immediately, and consult a physician if symptoms worsen or persist for more than 48 hours."

Hypersensitivity reactions may also occur with bacitracin, according to the Handbook of Nonprescription Drugs (10th edition), published by the American Pharmaceutical Association and The National Professional Society of Pharmacists, Washington, D.C. The handbook also states that tetracycline products may trigger reactions in allergic patients, "some of whom may have severe reactions even if exposure is by topical application only."

With repeated use on large areas, neomycin also fosters development of neomycin-resistant strains of Staphylococci bacteria. Neomycin products that include polymyxin B and bacitracin guard against this.

To prevent neomycin overuse, FDA limits the drug to ointments and creams, the most likely dosage forms for small wounds. Also, all OTC antimicrobials must be labeled for short-term use. The agency believes short-term use of neomycin ointments or creams on small wounds would not risk overuse. To reduce the risk even further, FDA requires labels for ointments and creams to identify a dose as "an amount equal to the surface area of the tip of a finger."

Another issue is the combination of a product with a local "caine" anesthetic, such as benzocaine, as is allowed for bacitracin ointment or a combination ointment of bacitracin, neomycin, or polymyxin B. The review panel was concerned an anesthetic might mask symptoms of infection, delaying treatment by a doctor. But FDA believes the required warnings on the label adequately inform consumers when to consult a doctor.

More About Antiseptics

In its proposed rule, FDA listed these active antiseptic ingredients as tentatively safe and effective: ethyl alcohol (48 to 95 percent), isopropyl alcohol, benzalkonium chloride, benzethonium chloride, camphorated metacresol, camphorated phenol, phenol, hexylresorcinol, hydrogen peroxide solution, iodine tincture, iodine topical solution, povidone-iodine, and methylbenzethonium. Five ingredients listed as tentatively effective only in combination products are ethyl alcohol (26.9 percent), eucalyptol, menthol, methyl salicylate, and thymol.

The proposal would ban numerous mercury ingredients and cloflucarban, fluorosalan and tribromsalan antiseptics as not generally recognized as safe and effective for OTC use.

FDA had requested study data on whether use of topical povidone-iodine affected thyroid function. In submitted data, iodine blood levels did increase after two weeks' use, but returned to normal when use was stopped. There was no effect on thyroid function.

Antiseptics would be labeled similarly to antibiotics, but with some differences.

Labels on camphorated metacresol, camphorated phenol, and phenol, for example, would warn, "Do not bandage."

"The drugs can be hard on the skin," says Debbie Lumpkins, a microbiologist in FDA's division of OTC drug evaluation. She explains that, "when bandaged, the skin gets damp, increasing absorption. Therefore, more drug enters the skin and may cause more damage than if you just left the wound uncovered." Labels for ethyl alcohol (48 to 95 percent) and isopropyl alcohol (50 to 91.3 percent) would warn: "Flammable, keep away from fire or flame."

For liquid antiseptics, labels would direct users to let the product dry before bandaging.

Comments on the proposal were minimal, Lumpkins says, emphasizing that FDA's evaluation of the ingredients is still very much an evolving process.

"Frequently," she says, "we find that one study or one article says one thing, and there's another study or article on the other side. We have to determine the facts. Literature searches that we can now do so easily help, but we won't find everything. We rely on people to bring things to our attention."

Recent publications advise against two currently marketed antiseptics. The National Safety Council's 1996 First Aid Pocket Guide states: "DO NOT use hydrogen peroxide. It does not kill bacteria, and it adversely affects capillary blood flow and wound healing." And the Handbook on Nonprescription Drugs states ethyl alcohol "is not a desirable wound antiseptic because it irritates already damaged tissue. The coagulum [crust] formed may, in fact, protect the bacteria."

The final rule will reflect FDA's evaluation of all the data, Lumpkins says. Thus, antiseptic ingredients proposed as safe and effective could be found unsafe or ineffective, or new ingredients could be added, depending on new information.

Whether using an OTC antibiotic or antiseptic, consumers should realize "there are limits to what the products can do," Lumpkins says. "People should read the label, and use the product appropriately. If they notice a change in their condition, or if there's redness or swelling, they shouldn't continue to try to treat it. They should see a doctor."

Dixie Farley is a staff writer for FDA Consumer.

Labeling Final Rule

Under the final rule, labels for topical antibiotics must:

• state the established name of the drug
• identify the drug as a "first-aid antibiotic"
• state the drug's approved use — for example: "First aid to help protect against infection in minor cuts, scrapes, and burns." (Allowed alternative wording includes "help prevent skin infection" or "help reduce the risk of bacterial contamination." Other descriptive statements may be added, provided they are truthful and not misleading.)
• warn:
• advise to clean the area, to use a small amount one to three times daily, and to cover with a sterile bandage if desired
• specify on ointments and creams to use "an amount equal to the surface area of the tip of a finger."

Combination products must give the established name of each active ingredient. Labels must identify any added anesthetic as such, include the directions and warnings in its monograph, and state: "First aid for the temporary relief of pain [or other approved alternative] in minor cuts, scrapes, and burns."

OTC Antibiotics

The following antibiotic products have been approved by FDA for use without a prescription. They are ointments unless otherwise noted:

Single-Ingredient Products

Bacitracin — Baciguent

Bacitracin zinc — Bacitracin Zinc

Chlortetracycline hydrochloride — Aureomycin

Neomycin sulfate — Neomycin, Myciguent Cream

Tetracycline hydrochloride — Achromycin

Combination Products

Bacitracin-neomycin — none currently marketed

Bacitracin-polymyxin B aerosol — none currently marketed

Bacitracin-neomycin-polymyxin B — Lanabiotic, Medi-Quik Triple Antibiotic, Clomycin Cream (with lidocaine anesthetic), Mycitracin Plus Pain Reliever (with lidocaine)

Bacitracin zinc-neomycin — none currently marketed

Bacitracin zinc-polymyxin B ointment, aerosol or powder — Polysporin, Polysporin Powder

Bacitracin zinc-neomycin-polymyxin B — Neomixin, Neosporin Original

Neomycin-polymyxin B ointment or cream — Neosporin Plus Maximum Strength Cream (with lidocaine)

Oxytetracycline-polymyxin B ointment or powder — none currently marketed.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.