Don't Swallow the Skin Lotion: FDA Trying to Save People From Themselves
May 13, 2010 - 8:08 AMThe Food and Drug Administration finds it necessary to warn the American public that swallowing an over-the-counter medication meant to be rubbed on the skin can have harmful effects.
The FDA says it has received reports of serious side effects -- including unconsciousness, hallucinations, and confusion -- in people who “mistakenly” swallowed Benadryl Extra Strength Itch Stopping Gel.
Although some over-the-counter liquid Benadryl products are supposed to be swallowed, Benadryl Extra Strength Itch Stopping Gel is not one of them, the FDA warned Wednesday in a consumer alert. People who swallow it can receive dangerously large amounts of the active ingredient, diphenhydramine.
The topical remedy comes in a bottle similar to suntan lotions, and the label does say it’s for use on the skin only.
But to be on the safe side, the manufacturer, Johnson and Johnson, has changed the product label, adding a new, prominent instruction reading, “For Skin Use Only.” And the company has added a sticker to the product cap, also reading “For Skin Use Only.”
The FDA says Johnson & Johnson also has “initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.”
The FDA is now encouraging manufacturers of similar products to follow Johnson and Johnson’s example and adopt similar changes to their labeling and packaging.
The agency also is reminding consumers to ““read the ‘Drug Facts’ box on the label, and check with a doctor or pharmacist if you are not sure which over-the-counter product is right for you.”
The FDA says consumers should store products for the skin separately from remedies that are swallowed.
And finally, the FDA notes that Benadryl Extra Strength Itch Stopping Gel is safe and effective when used on the skin, as directed.