Tretinoin; Benzoyl Peroxide Topical Cream

What is this medication?

TRETINOIN; BENZOYL PEROXIDE (TRET i noe in; BEN zoe ill per OX ide) is a combination topical cream. It is used on the skin to treat acne.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TWYNEO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• large area of burned or damaged skin
• skin conditions, disease, or sensitivity
• an unusual or allergic reaction to tretinoin, benzoyl peroxide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for external use only. Do not take by mouth. Wash your hands before and after use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your health care provider tells you to stop.

Apply a thin film of the medicine to the affected area. Do not apply to burned or damaged skin.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 9 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• medicines or other preparations that may dry your skin such as salicylic acid
• medicines that increase your sensitivity to sunlight such as tetracycline or sulfa drugs

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse. Do not use other products that dry the skin. Examples include abrasive cleaners or products with alcohol in them. Do not use other acne products on the same areas of the skin as this one unless your health care provider tells you to use both. This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths. Avoid using this medicine on skin with eczema or a sunburn because it may cause severe irritation. This medicine may bleach hair or colored fabrics. Avoid getting the medicine in your hair or on your clothes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• burning, itching, crusting, or swelling of the treated areas

Side effects that usually do not require medical attention (report these to your doctor or health care provider if they continue or are bothersome):

• increased sensitivity to the sun
• mild skin irritation, redness, or dryness
• peeling of treated skin

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Keep the container tightly closed. Throw away any unused medicine 30 days after opening or 12 weeks after getting your prescription, whichever is first. To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.