J&J Adds Safety Statement to Benadryl Gel Label

Johnson & Johnson (J&J) has agreed to add a new, prominent statement on the label for its Benadryl Extra Strength Itch Stopping Gel: “For Skin Use Only.” The action is a result of serious adverse events reported to the FDA by consumers who have mistakenly swallowed the product, whose active ingredient is diphenhydramine. Most OTC Benadryl products are intended to be ingested, but the gel is only safe and effective when applied directly to the skin. Large doses of diphenhydramine can cause unconsciousness, hallucinations and confusion, the FDA said.
Washington Drug Letter