May 13, 2010
Here's another example of why it's important to read the label before you use a medication.
The Food and Drug Administration (FDA) says it has received reports of serious side effects - things like -- unconsciousness, hallucinations, and confusion -- in people who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel.
While some over-the-counter liquid Benadryl products are 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, says FDA. But people who swallow it can receive dangerously large amounts of the active ingredient, diphenhydramine.
Advice for consumers
• Products for the skin should separately from products that are meant to be swallowed.
• Read the "Drug Facts" box on the product's label to identify active ingredients, directions for use, and warnings before using any over-the-counter drug product.
• Check with a health care professional such as your doctor or pharmacist if you are not sure which over-the-counter product is right for you.
• Report any side effects from the use of over-the-counter products. to FDA's MedWatch Adverse Event Reporting Program online, by regular mail (using postage-paid, pre-addressed FDA form 3500), by fax (1-800-FDA-0178), or by phone (1-800-332-1088).
Product package changes
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"
• attached a sticker to the cap of the product that says "For Skin Use Only"
• initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel
Other topical gels
Many pharmacies and grocery stores sell other diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. Consumers should not swallow these products either. Swallowing them can result in serious side effects.
FDA is encouraging manufacturers of similar products to follow Johnson and Johnson's example and adopt similar changes to their labeling and packaging.
