Cleanse & Treat topical

You should not use this medicine if you are allergic to benzoyl peroxide, salicylic acid, or aspirin.

To make sure benzoyl peroxide and salicylic acid topical is safe for you, tell your doctor if you have any allergies or other medical conditions.

FDA pregnancy category C. It is not known whether benzoyl peroxide and salicylic acid topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether benzoyl peroxide and salicylic acid topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Benzoyl peroxide and salicylic acid topical should not be used on a child younger than 12 years old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Benzoyl peroxide and salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. Before you start using this medicine, you may choose to apply a "test dose" to see if you have a reaction. Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day.

Use only mild skin cleansers or those your doctor has prescribed.

Apply the medicated pad to clean, dry skin twice per day or as directed by your doctor. Do not rinse off the medicine unless it causes severe skin irritation just after applying.

Do not share this medication with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat. Keep each medicated pad in its foil pouch until you are ready to use it.

Do not take by mouth. Benzoyl peroxide and salicylic acid topical is for use only on the skin. Avoid getting this medication in your nose or mouth. If this does happen, rinse with water. Do not use this medicine on sunburned, windburned, dry, chapped, irritated, or broken skin.

If this medication gets in your eyes, rinse with water.

Avoid using other medications on the areas you treat with benzoyl peroxide and salicylic acid topical unless your doctor tells you to.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Benzoyl peroxide and salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward.

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using benzoyl peroxide and salicylic acid topical and call your doctor at once if you have:

• severe skin irritation after using the medicine;

• scaly or peeling skin;

• redness or swelling of treated skin; or

• nausea, vomiting, diarrhea.

Common side effects may include:

• dry skin or mild irritation;

• dizziness; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to benzoyl peroxide / salicylic acid topical: topical pad

Dermatologic

Excessive drying has been associated with skin peeling, irritation, erythema, and possible edema.[Ref]

Dermatologic side effects have included allergic contact dermatitis and excessive drying (4%).[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and diarrhea have been reported.[Ref]

Nervous system

Nervous system side effects including dizziness, loss of hearing, tinnitus, and lethargy have been reported.[Ref]

Respiratory

Respiratory side effects including hyperpnea have been reported.[Ref]

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