Show #88, July 2009: Warning on Accidental Ingestion of Benadryl Topical Gel

FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring hospitalization or emergency treatment.

Benadryl Gel contains the antihistamine diphenhydramine as well as camphor, which is toxic and potentially fatal if ingested. Camphor can cause a variety of symptoms, such as burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma, and respiratory difficulties. It is not clear whether the adverse reactions experienced by the people who ingested Benadryl Gel were due to the camphor or to an overdose of Benadryl, since the symptoms can be similar.

FDA and ISMP suggest that the way the product is packaged may contribute to these errors. Instead of being packaged in a tube, like many topical products, the Benadryl Gel is available in a 4 ounce bottle. That means it can be mistaken as an oral liquid, particularly since the bottle has the same shape and size as other oral liquid products. And although the Benadryl brand now includes many combination products, most are intended for oral or parenteral use. ISMP also points out that although the words "external use" appear on the back of the bottle, the front of the bottle says "Topical Analgesic" in small letters that consumers could miss or not understand.

Here are some ways that pharmacists can help consumers avoid confusion:

• Keep topical products separated from the ones intended for ingestion.

• Advise consumers to keep topical and oral products separated when they store OTC products and prescription medicines at home.

• Remind consumers to read the drug facts label before using OTC products.


Additional Information:
ISMP Medication Safety Alert! Benadryl topical product poses danger if swallowed. January 29, 2009.
Drug Topics – The News Magazine for Pharmacists. Taylor, Kellie; PharmD, MPh. Benadryl Itch Stopping Gel Goes on the Body, Not into the Mouth. Don't swallow it. November 10, 2008.


II - Benadryl topical product poses danger if swallowed
From the January 29, 2009 issue

Over the holidays, our consumer website (www.ConsumerMedSafety.org) featured a warning about BENADRYL ITCH STOPPING GEL (diphenhydrAMINE), an over-the-counter (OTC) topical product used to relieve itching. The FDA adverse event reporting system has collected at least seven reports of people who have swallowed the product, which has led to serious adverse reactions requiring hospitalization or emergency treatment.

Benadryl Gel contains diphenhydramine as well as camphor, which is known to be toxic if swallowed. Camphor can cause a variety of symptoms including burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma, and irregular respirations. Its ingestion has occasionally led to fatalities. Camphorated oil, another topical product, was removed from the market in the 1980s after multiple incidents of accidental ingestion (www.fda.gov/ cder/otcmonographs/Camphorated_Oil/ camphorted_oil_human_use_19820 921.pdf). But it’s not clear whether the adverse reactions experienced by people who swallowed Benadryl Gel were due to the camphor component of the product or the Benadryl itself, since the symptoms can be similar.

The packaging and labeling of Benadryl Gel is one of the key contributing factors associated with these errors. Benadryl is an antihistamine that has been on the market for many years. Its line of products has grown over the years, and it now includes many combination products to treat various symptoms. These products are widely available as a topical cream, oral liquid, capsule, and injectable product. Although the topical cream has long been available, all the other Benadryl products are intended for oral or parenteral administration. Further, instead of being packaged in a tube, like many topical products, the Benadryl Gel is available in a 4 ounce bottle. The clear gel, which has a consistency more like liquid than a gel, can easily be mistaken as an oral liquid, particularly since the bottle has the same shape and size as other oral liquid products.

In our opinion, the labeling of the product (see the photo on page 1) does not sufficiently warn consumers not to ingest the product. You will notice that the label states in very small print, “Topical Analgesic,” but this statement is nestled among other product information and easily missed. If it is seen, it’s also possible that consumers won’t understand this medical terminology. “External Use Only,“ “Apply ONLY to the skin,” or “Do NOT swallow” would be better statements on the front label panel. “External” use is mentioned on the other side of the bottle under the Drug Facts section, but that information was apparently missed in the abovementioned cases.

We spoke with a company representative to ask them to make the changes suggested above. The company spokesman agreed that his team would look into our suggestions and get back to us. We also hope they will consider adding a picture on the label that implies topical use for non-English speaking consumers.


III - Benadryl Itch Stopping Gel goes on the body, not into the mouth. Don't swallow it.
Nov 10, 2008
By: Kellie Taylor, PharmD, MPh
Drug Topics

Key Points
Benadryl Itch Stopping Gel contains camphor and is for external use only
It has been involved in several cases of accidental oral ingestion
The incidents resulted in hospital visits

The U.S. Food and Drug Administration (FDA) wants to alert consumers and healthcare professionals that one of the topical products, Benadryl Itch Stopping Gel, has been involved in several cases of accidental oral ingestion. This product contains diphenhydramine HCl (2 percent) and zinc acetate (1 percent) as the active ingredients, but also lists camphor as an inactive ingredient. Camphor is a common ingredient in many topical OTC medications, and its use is limited to topical and vaporized administration only. Camphor is not intended for oral administration and can be toxic when administered orally. Camphor can cause gastrointestinal symptoms (burning of the mouth and throat, nausea, and vomiting), neurological effects (irritability, confusion, seizures, coma, and apnea), and has been associated with death in some cases.

In the FDA's Adverse Event Reporting System (AERS) database, seven reports of medication errors involving accidental oral ingestion of Benadryl Itch Stopping Gel in adults and children have been identified. The contributing factors to these errors may be due to the packaging configuration of the container and concurrent marketing of oral liquid Benadryl products. Consumers can mistake the Benadryl Itch Stopping Gel product for an oral product instead of a topical product because the container is shaped like a four-ounce bottle of oral liquid medication, with a tapered top. Additionally, the viscosity of the gel is very thin, resembling the viscosity of an oral liquid product rather than a gel product.

The incidents of accidental oral ingestion of Benadryl Itch Stopping Gel resulted in serious adverse events that required hospitalization or an emergency-room visit. The reactions reported resulted from acute, one-time ingestion of the product, in quantities ranging from one-half teaspoon to four tablespoons. It's difficult to assess whether the adverse events resulted from exposure to camphor or diphenhydramine, since the overdose symptoms of camphor (nausea, vomiting, dizziness, headache, and convulsions) and diphenhydramine (nausea, confusion, convulsions, delirium) can appear similar. In light of the serious outcomes associated with these medication errors, the FDA is recommending that pharmacists counsel parents to use caution when purchasing and storing topical products.


Here are some measures pharmacists can take to help avoid confusion:

In the pharmacy setting, physically separate topical products from products intended for ingestion.
Similarly, advise consumers to keep topical and oral products separated when they store OTC products and prescription medicines at home.
Remind consumers to read the drug facts label for important product information before administering OTC products.

If you become aware of medication errors involving Benadryl Itch Stopping Gel or other products, report them to the FDA MedWatch program online at http://www.fda.gov/medawatch/.

KELLIE TAYLOR, PharmD, MPh, is Team Leader, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA.