ISMP Safe Medicine November/December 2008, Volume 6, Number 6. ©2008 ISMP

Brand name medicines appear in green; generic medicines appear in red.

Benadryl Gel for the skin has been mistaken as an oral medicine

Our consumer website (www.ConsumerMedSafety.org) recently featured a warning about an over-the-counter (OTC) medicine, BENADRYL ITCH STOPPING GEL (diphenhydrAMINE). The US Food and Drug Administration has collected at least seven reports of people who have swallowed the gel instead of putting it on their skin. This led to serious side effects that required treatment in a hospital.   

Benadryl Gel is intended to be used on your skin. It contains a common medicine used to help relieve itching called diphenhydramine. The medicine also contains camphor, which is known to be harmful if swallowed. Camphor can cause a variety of problems if swallowed, including:

1. Burning of the mouth and throat
2. Nausea and vomiting
3. Irritability and confusion
4. Irregular breathing
5. Seizures
6. Coma.

Swallowing camphor has also led to deaths. Because of this, camphorated oil was taken off the market in the 1980s. Camphorated oil is another medicine that was supposed to be put on the skin. There were numerous reports of people accidentally swallowing the oil and dying. But in the case of Benadryl Gel, it’s not clear whether the bad side effects were caused by the camphor in the medicine or the Benadryl (diphenhydramine) itself. The side effects for both camphor and Benadryl are similar.

Although Benadryl skin cream has been around a long time, most Benadryl products are intended to be taken by mouth. And instead of coming in a tube, like most products you put on your skin, the Benadryl Gel comes in a 4-ounce bottle (see the picture below). The clear gel is thin like a liquid, too. This makes it easy to think it should be swallowed like other oral liquid medicines that come in similar-looking bottles.

Unfortunately, the label on the Benadryl Gel does not have a clear warning that it should not be swallowed. If you look at the picture of the bottle below, you will notice that “Topical Analgesic” is listed on the label. Some people may not know what this means. “Topical” means something that should be applied only to the skin, and “Analgesic” means something that relieves pain and discomfort. This statement also appears in very small print, nestled among other product information and easily missed. “External Use Only,” “Apply ONLY to the skin,” or “Do NOT swallow” would be better statements on the front of the label. “External” use is mentioned on the side of the bottle, but again, this information is easy to overlook.   

We spoke with someone from the company that makes Benadryl Gel to ask them to make it clear on the front of the label that the product should not be swallowed.

 
Figure 1. Benadryl Gel is dangerous if swallowed.