FDA has received reports of serious side effects—such as unconsciousness, hallucinations, and confusion—in people who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel.
Although there are other over-the-counter liquid Benadryl products intended to be swallowed, Benadryl Extra Strength Itch Stopping Gel is NOT one of them. It is a topical product meant for use only on the skin.
Benadryl Extra Strength Itch Stopping Gel is safe and effective when used on the skin as directed. People who swallow it can receive dangerously large amounts of the active ingredient, diphenhydramine.
Advice for Consumers: In your home, store products for the skin separately from products that should be swallowed.
Report any side effects from the use of over-the-counter products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
o Regular Mail: Use postage-paid, pre-addressed FDA form 35005
o Fax: 1-800-FDA-0178
o Phone: 1-800-332-1088
To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has changed the product label to add a new, prominent statement “For Skin use Only” and attached a sticker to the cap that says the same thing.