Warning on Swallowing Benadryl Topical Gel

FDA is warning people not to swallow Benadryl Extra Strength Itch Stopping Gel, an OTC product that should only be used on the skin.

FDA has received a number of reports where people experienced serious side effects after mistakenly swallowing this product, potentially exposing them to large amounts of the active ingredient, diphenhydramine. The reported effects included hallucinations, confusion, tachycardia and unconsciousness.

Several factors may have contributed to the problem. For example, a number of oral diphenhydramine products are sold under the Benadryl name, so people may associate "Benadryl" only with oral medications. And the gel was only identified as a "Topical Analgesic" in small letters on the front of the bottle.

To help fix this situation, the manufacturer has now added a prominent statement to the front of the bottle and the bottle cap that says, "For skin use only."

Pharmacists and other healthcare professionals should remind patients that Benadryl Extra Strength Itch Stopping Gel and similar topical products should only be applied to the skin.

FDA Patient Safety News: July 2010
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=100#8

Category:

Education

Tags:

• Benadryl
• itch
• gel
• diphenhydramine
• skin
• FDA