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FDA: Serious Side Effects from Swallowing Topical Benadryl Product
Date:5/12/2010

nt for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:

  • 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.

The FDA encourages manufacturers of similar products to adopt similar changes to their labeling and packaging.  

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.

Consumers and health care professionals are encouraged to report adverse side effects to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

For more information

FDA 101: Medication Errors

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048644.htm

Media Inquiries: Shelly Burgess, 301-796-4651,

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

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