Binora Topical

Benzoyl peroxide topical is used to treat acne and may be used for other skin conditions as determined by your doctor.

This medicine is available without prescription. Some of the skin products are available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling
• skin rash

• Difficult breathing
• fainting
• hives
• itching
• swelling of the eyes, face, lips, or tongue
• tightness in the throat

Get emergency help immediately if any of the following symptoms of overdose occur:

• Burning, itching, scaling, redness, or swelling of skin (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dryness or peeling of the skin (may occur after a few days)
• feeling of warmth, mild stinging, and redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Skin reactions such as peeling, itching, irritation, and reddened skin may occur, especially at the start of treatment. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. You may need to apply smaller amounts of the drug or use it less often. Consult your doctor or pharmacist for more details.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: dapsone used on the skin.

Applies to benzoyl peroxide topical: topical bar, topical cream, topical foam, topical gel/jelly, topical liquid, topical lotion, topical pad, topical soap, topical solution

Along with its needed effects, benzoyl peroxide topical (the active ingredient contained in Binora) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzoyl peroxide topical:

• Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling
• skin rash

• Difficult breathing
• fainting
• hives
• itching
• swelling of the eyes, face, lips, or tongue
• tightness in the throat

Get emergency help immediately if any of the following symptoms of overdose occur while taking benzoyl peroxide topical:

• Burning, itching, scaling, redness, or swelling of skin (severe)

Some side effects of benzoyl peroxide topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dryness or peeling of the skin (may occur after a few days)
• feeling of warmth, mild stinging, and redness of the skin

Applies to benzoyl peroxide topical: compounding powder, topical bar, topical cream, topical foam, topical gel, topical kit, topical liquid, topical lotion, topical pad, topical soap

Dermatologic

Very common (10% or more): Peeling, application site erythema
Common (1% to 10%): Dryness, pruritus, contact sensitization reactions
Uncommon (0.1% to 1%): Burning sensation
Frequency not reported: Contact dermatitis, application site rash, application site discoloration, application site reactions (irritation and pain)[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions, including application site hypersensitivity and anaphylaxis[Ref]

General

The most commonly reported side effects were peeling and application site erythema.[Ref]

Other

Frequency not reported: Swelling of the face[Ref]

Some side effects of Binora may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.