FDA Warns Against Swallowing J&J’s Benadryl Extra Strength Itch Stopping Gel

The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin.

FDA warned that people swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.

FDA said that many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers also avoid swallowing these products.

Carol Holquist, director of division of medication error prevention and analysis of FDA, said: “Consumer confusion and incorrect product use are serious public health issues. FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed.”

To help consumers recognise that Benadryl Extra Strength Itch Stopping Gels meant for use on the skin, Johnson and Johnson has taken actions by changing the product label to add a new, prominent statement ‘For Skin Use Only’, attached a sticker to the cap of the product that says ‘For Skin Use Only’ and initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.

Reportedly, the repackaged product is currently stocked in retail stores. The FDA reminds consumers and health care professionals to always read the ‘Drug Facts’ box to identify active ingredients, directions for use, and warnings before using any OTC drug product.