![]() ![]() ![]() Patient ages ranged from 26 months to 84 years old.Of these, 7 were considered serious because patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. Report adverse events or medication errors involving OTC products to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.ĭuring FDA's evaluation of medication errors associated with Benadryl Extra Strength Itch Stopping Gel, the agency reviewed the adverse event reports submitted to both FDA's Adverse Event Reporting System (AERS) and the manufacturer, Johnson & Johnson.īetween 20, a total of 121 cases of mistaken ingestion of Benadryl Extra Strength Itch Stopping Gel were reported to the manufacturer.Whenever possible, consider storing oral and topical products separately on store shelves this may help reduce consumer confusion about how the products are used.When recommending an OTC product to a consumer, discuss the use(s) and route of administration of the product.Report any side effects from the use of OTC products to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.Check with a healthcare professional or pharmacist if you are not sure which OTC product is right for you.Read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any over-the-counter (OTC) drug product.In your home, store products for the skin separately from products that should be swallowed.These products are safe and effective when used on the skin as directed.Benadryl Extra Strength Itch Stopping Gel and similar topical products used on the skin should NOT be swallowed.Swallowing these products can also result in adverse events.įDA encourages manufacturers of similar products to follow Johnson and Johnson's example and adopt similar changes to their labeling and packaging. It is important that consumers not mistakenly swallow these products too. Many pharmacies and grocery stores sell other diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.Attached a sticker to the cap of the product that says "For Skin Use Only.".Changed the product label to add a new, prominent statement "For Skin Use Only.".To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions: This can result in serious adverse events, such as unconsciousness, hallucinations, and confusion (see Data Summary). Swallowing it can result in people receiving dangerously large amounts of the active ingredient, diphenhydramine. Benadryl Extra Strength Itch Stopping Gel should NOT be swallowed.īenadryl Extra Strength Itch Stopping Gel is safe and effective when used on the skin as directed. Although there are over-the-counter liquid Benadryl products intended to be swallowed, Benadryl Extra Strength Itch Stopping Gel is a topical product that is used on the skin. Food and Drug Administration (FDA) has received reports of adverse events in consumers who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel. ![]() Additional Information for Healthcare Professionals ![]()
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