Benzoylside effects

benzoyl peroxide 0.025 MG/MG Topical Gel

Adverse reactions

During clinical trials, the most frequently reported adverse event in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% and vehicle groups. Local Adverse Events - all causalities in >/= 1% of patients Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% n = 420 Vehicle n = 168 Application Site Reaction 13 (3%) 1 (< 1%) Dry Skin 50 (12%) 10 (6%) Pruritis 8 (2%) 1 (< 1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (< 1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 23, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Warnings

For external use only Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

avoid unnecessary sun exposure and use a sunscreen

avoid contact with the eyes, lips, and mouth

avoid contact with hair and dyed fabrics, which may be bleached by this product

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if

irritation becomes severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Contraindications

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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