Here’s a warning about a Benadryl (diphenhydramine) over-the-counter (OTC) product that is posing a danger to patients because it is being used incorrectly. The packaging and labeling of BENADRYL ITCH STOPPING GEL may be contributing to dangerous confusion.
Benadryl Itch Stopping Gel is ONLY meant to be used by spreading it on the skin for itching! However, in the FDA adverse event reporting system there are at least seven reports of people swallowing the product instead of using it as intended.
Among the ingredients in Benadryl Itch Stopping Gel are diphenhydramine (an antihistamine component) and camphor, which is known to be toxic if swallowed. Camphor can cause GI symptoms including burning of the mouth and throat and nausea and vomiting, irritability, confusion, seizures, coma and paused breathing. It has been associated with death in some cases. A product known as camphorated oil, also for use only on the skin, was sometimes accidentally swallowed. It was removed from the market in the 1980s Click here.
According to reports sent to FDA about Benadryl Itch Stopping Gel, people swallowing it have had serious adverse reactions that required hospitalization or an emergency-room visit. It’s not clear though whether the symptoms were due to the camphor component or to Benadryl itself since symptoms can be similar.
Why is this happening?
One possible reason is that most Benadryl products are available in pill or oral liquid form. Benadryl has been around for many years and widely used as an antihistamine for people with allergies or cold symptoms. Over the years the Benadryl line of products has grown and now includes many combination products for different symptoms. Although there has been a cream available for use on the skin, the other products are all for oral or use by injection. So people are used to swallowing Benadryl products. Benadryl Itch Stopping Gel though is in a 4 ounce bottle that can easily be mistaken for an oral liquid bottle since it is the same shape and size as many other oral other liquid products. The liquid gel itself has a thickness that is more like a liquid than a gel.
There’s something else that may be contributing to this serious problem. In our opinion, the labeling of the product (see photo) does not sufficiently warn against swallowing it. Notice that in very small letters mixed in with other information it says “topical analgesic.” Not only is it hard to see those words but a lot of people probably won’t understand this medical terminology. “Topical” means the product is only for application to the skin. An analgesic is used for pain. That’s not even the correct word since this is primarily an anti-itch product, and not much of a pain medication. The proper word for that would be "anti-pruritic." Better wording would be “External Use Only" or "Apply ONLY to the skin.” That wording also should be much more prominent and on the front label panel.
This terrible, ongoing, situation should remind all of us of the importance of reading and understanding medication labels. Please always read the bottle label and drug facts label that is affixed to OTC products. Read this thoroughly and if you are not sure you understand exactly how the product is to be used, be sure to ask your pharmacist (a good reason to purchase OTC drug products either in the pharmacy or where one is on located such as a supermarket with a pharmacy!).
Until this product is repackaged, we hope that pharmacists and others who stock Benadryl Itch Stopping Gel will keep this product separate from products that ARE supposed to be swallowed. And that’s important for you to do too!! If you have this product, keep it away from other medications. We recommend that stores selling this product take the extra step to label shelves about the product being for application to the skin only. For other tips on storing drugs safely, do a search on the word “storage” in the search field at the top of this page.
We are asking FDA to contact the company and have them make the changes we suggest above, including new labeling and packaging and making the liquid much thicker so it won’t be confused with an oral liquid. Until then, this important safety issue will remain with this product.
If you become aware of medication errors involving Benadryl Itch Stopping Gel or other products, please be sure to report them on this website: Click Here. We’ll be sure to pass the information on to FDA and the manufacturer and you can let us know whether or not you want to be identified to them. We’ll also consider whether new or additional warnings are necessary here on consumermedsafety.org and our health professional site. Click here and you will be taken to our professional site. | 
