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Mistaken Ingestion of Topical Benadryl Extra Strength Itch Stopping Gel
The FDA has received reports of serious adverse effects occurring in people who mistakenly swallowed topical Benadryl Extra Strength Itch Stopping Gel.
People who swallow the gel can ingest a dangerous amount of diphenhydramine, resulting in adverse effects that may include unconsciousness, hallucinations, and confusion. In response to these reports, 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 has encouraged manufacturers of similar products to adopt similar changes to their labeling and packaging.
Vita Breath Dietary Supplement
The FDA is notifying health care professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. A sample of Vita Breath analyzed by the New York City Department of Health and Mental Hygiene contained 1,100 parts per million of lead, which is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning.