openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
WARNINGS AND PRECAUTIONS Irritation including peeling, itching and/or redness may occur, especially at the start of treatment. If any of these effects persist or worsen, stop using and contact your doctor immediately. Smaller amounts of the drug may need to be applied less often. Consult your doctor for instructions. For external use only. Keep away from the eyes and mucous membranes. If severe irritation or swelling develops, discontinue use and seek appropriate therapy.
ADVERSE REACTIONS The most frequent adverse reactions to benzoyl peroxide are irritation and contact dermatitis. Although 0.5% hydrocortisone is considered safe, the following adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. This is not a complete list of possible adverse effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.