Benzoyl Peroxide Lotion

• It is used to treat pimples (acne).

• If you have an allergy to benzoyl peroxide or any other part of benzoyl peroxide lotion.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have very sensitive skin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take benzoyl peroxide lotion with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Certain acne products that contain benzoyl peroxide or salicylic acid can rarely cause very bad and sometimes life-threatening allergic reactions or very bad irritation. Before first use, you may need to follow certain steps to make sure you do not have an allergic reaction. Use benzoyl peroxide lotion as you were told by the doctor or read the package label. Talk with the doctor.
• Do not put on irritated skin.
• Do not put on sunburned skin.
• Do not leave this medicine on the skin longer than you have been told by the doctor.
• Use of other skin products while using benzoyl peroxide lotion may cause more irritation.
• Talk with your doctor before you use other drugs or products on your skin.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Use care when putting on. It may bleach hair or colored fabric.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using benzoyl peroxide lotion while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

General: For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy: Category C- Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.

4% Benzoyl Peroxide Cleansing Lotion is supplied in 10.5 oz. (297 g) plastic bottles, NDC 49769-285-11
8% Benzoyl Peroxide Cleansing Lotion is supplied in 10.5 oz. (297 g) plastic bottles, NDC 49769-286-11.

Store at controlled room temperature, 20°-25° C (68°-77° F).

KEEP THIS AND ALL MEDICTIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Rev. 02/10 285/286-10
P0566

Below represents the current packaging being used:

285-11 Label:

286-11 Label: