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FDA Warns: Don't Swallow Your Benadryl Lotion


Wednesday the FDA and Johnson & Johnson notified consumers and healthcare professionals of changes to the labeling of Benadryl Extra Strength Itch-Stopping Gel. The changes are in response to the FDA receiving 121 cases of people ingesting the gel between 2001 and 2009.

The changes to the graphics and information displayed on the front of the product container are intended highlight the “For Skin Use Only" of the anti-itch gel in big letters on the front of the bottle. This phrase will replace the currently used phrase “topical analgesic.”

Benadryl Extra Strength Itch-Stopping Gel should only be used topically. Swallowing the gel can result in the person taking dangerously large amounts of the active ingredient diphenhydramine.

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Of the 121 cases of ingestion of Benadryl Extra Strength Itch Relief Gel reported, 7 were considered serious as the patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. The serious adverse events of ingestion of the gel can include hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and inability to speak.

While the gel’s main ingredient, diphenhydramine, is found in formulations intended to be taken by mouth, the gel formulation isn’t. Pill, capsule, and liquid formulations used for allergy symptoms, motion sickness and insomnia have regulated dose amounts per capsule/pill or teaspoon.

It is important for all of us consumers to read the label very carefully for all medications and to use the product as intended.

Food and Drug Administration