Over the Counter Drug Options for Cuts, Scrapes and Burns

by Food and Drug Administration (FDA)

A half-inch scar on my left knee is a graphic reminder of a painful scrape at age 7. Also painful was the burn of Merthiolate antiseptic, applied as first aid to ward off infection.

Today's approved over-the-counter topical (used on the skin) first-aid antimicrobials are less irritating and more effective than Merthiolate, which contains the mercury drug thimerosal. The Food and Drug Administration has approved seven topical OTC antibiotics (see "OTC Antibiotics") and is evaluating OTC topical antiseptics under a proposed rule. The proposal would ban numerous antiseptics, including mercurials, as ineffective and some, including thimerosal, as also unsafe.

Antibiotics are also available by prescription as injectable and oral medicines and medicines for the eye and ear. They are used to treat infections. While some can kill a limited number of bacteria, other varieties affect many bacteria.

Antiseptics weaken microbes, but don't usually kill them. Health-care antiseptics in soaps and other products help prevent the spread of infection in medical facilities.

OTC first-aid antibiotics and antiseptics are applied to the skin to help prevent infection in minor cuts, scrapes and burns.

"Used topically, OTC antimicrobials inhibit the growth of bacteria, but don't necessarily kill them all," says Audrey Love, a microbiologist with the division of OTC drug evaluation in FDA's Center for Drug Evaluation and Research. "If an injury is extensive," Love says, "it should be taken care of by a doctor. But consumers have to consider for themselves, based on reading the labeling, whether a product is something they should use."

FDA has published rules (monographs) establishing adequate labeling for OTC antimicrobials, and conditions under which products would be generally recognized as safe and effective for use without medical supervision. The final antibiotics rule (1987) and proposed antiseptics rule (1991) specify active ingredients and concentrations, as well as labeling information such as product identification, indications for use, warnings, and directions for use. All drugs must meet the agency's good manufacturing practice requirements for product identity, strength, quality, and purity.

Some Restrictions

OTC first-aid antimicrobials are for use only up to one week. If an injury persists or worsens after this time, the label warns consumers to stop use and consult a doctor.

The products are not for existing infections, animal bites, sunburn, punctures, or eye injuries. Nor should they be used for cuts, scrapes or burns needing medical care, such as:

• cuts that are deep, continue bleeding, or may require stitches
• scrapes with imbedded particles that can't be flushed away
• large wounds
• burns more serious than a small reddened area.

Use of an antibiotic or antiseptic does not in itself constitute first-aid treatment of a minor wound.

A panel of experts convened by FDA defined first aid as "a process that includes initial adequate cleansing which may or may not be followed by application of a safe, nonirritating product which does not interfere with normal wound healing and which may reduce the bacterial numbers and help prevent infection." (From 1972 to 1981, at FDA's request, 16 outside panels evaluated marketed OTC drugs. Their charge completed, the panels no longer meet.)

FDA requires that labels for antibiotics advise users to first "clean the affected area." Antiseptics also would be labeled with the advice.

Because topical antimicrobials are not totally effective in killing bacteria, FDA does not allow firms to place the claim "Helps kill bacteria" in the same area as the required information. FDA believes the term "kill" implies the product will eliminate all bacteria and could be misleading if appearing with the required term "infection" (or alternate term "bacterial contamination") in the label's indications section. The claim may be used, though, as additional information elsewhere in the label.

More About Antibiotics

In its final rule, FDA listed these antibiotic active ingredients as safe and effective: bacitracin, bacitracin zinc, chlortetracycline hydrochloride, tetracycline hydrochloride, neomycin sulfate, oxytetracycline hydrochloride, and polymyxin B sulfate — the latter two only for combination products because of their limited effectiveness against certain microorganisms when used alone.

The rule does not allow the previously marketed antibiotic gramicidin, because it has the potential to break down red blood cells when absorbed through fresh wounds. The agency called for a welldesigned, double-blind study (where neither patient nor doctor knows who gets the drug) to show gramicidin's effects.

The data on which FDA based its approval of the other antibiotics included a well-controlled study of minor skin injuries or insect bites in 59 children. Streptococcal infection developed in 15 of the 32 receiving a topical placebo and in three of the 27 receiving a topical antibiotic. Twelve of the 15 eventually needed oral antibiotics, and one of the three did.

The agency agreed with comments that many such injuries are self-healing, but that some do not heal without treatment and it is impossible to make this distinction at the time of injury.

Also, says FDA's Love, there's always a chance someone can be allergic to a drug, prescription or OTC. "People who tend to be allergic," she says, "should talk to their doctor or pharmacist before trying any OTC medicine for the first time."

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.