Warning. Do NOT swallow Benadryl Itch Stopping Gel!


FDA has followed up on previous warnings on this website regarding cases where consumers accidentally swallowed a Benadryl (diphenhydramine) over-the-counter (OTC) product meant to be applied to skin, never ingested. The packaging and labeling of BENADRYL ITCH STOPPING GEL has been 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 being injured after swallowing the product instead of using it as intended.

Now there are 8! A gentleman wrote to us recently to warn others not to store this product in your cabinet where you keep cough syrup. He said, do yourself a favor and remove it. Just two hours before, he went into the kitchen and opened the cabinet door to get some Benadryl cough syrup. It was dark and the bottle said Benadryl GEL and he thought it was his child's cough syrup. One small swig and he knew he had made a mistake. He threw it up and his lips were numb for two hours.

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.

Benadryl itself can be toxic if given in overdose, which is what would likely happen when swallowing Benadryl Itch Stopping Gel.

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. The cap can be screwed right off and the liquid can be poured out, just like the cold medicine.

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.

We did ask 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. In a recent FDA announcement we learned that the company has already begun to take steps to put this problem in its past. A sticker has been added to the cap to indicate the product is for use on the skin.

The FDA website has additional information and some pictures of temporary labeling changes. Click here

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!). Also, never take medicines in the dark, as this gentleman did. It makes it difficult to read product labels.

Until this product is repackaged, consumers must be on guard, and 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. Otherwise the product should not be stocked at all. For other tips on storing drugs safely, do a search on the word “storage” in the search field at the top of this page.

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.

Created on May 13, 2010

Medication Safety Alerts

FDA Safety Alerts

Show Your Support!

ISMP needs your help to continue our life saving work