Retin-A MICRO®
(ret-in-A MY-kroe)
(tretinoin gel microsphere, 0.1 and 0.04%)
For Topical Use Only

Read this information carefully before you start to use your medicine and each time you get more medicine. There may be new information about this medicine when you get your prescription renewed. This leaflet provides a summary of the information about Retin-A MICRO®. It does not include everything there is to know about your medicine. This information does not take the place of talking with your doctor; so, if you have any questions or are not sure about something, ask your doctor or pharmacist.

What is the most important information I should know about Retin-A MICRO®?

Tell your doctor if you are pregnant, think you are pregnant, trying to get pregnant, or are breast feeding. If you become pregnant while using Retin-A MICRO®, contact your doctor right away.

Retin-A MICRO® may make your skin very dry, red, swollen or blistered. Contact your doctor if these side effects bother you.

Use other acne medicines with Retin-A MICRO® only on your doctor's advice and follow your doctor's instructions carefully. The medicines you have used in the past might cause too much redness or peeling.

Avoid sunlight or sunlamps and medicines that may make you more sensitive to sunlight. Your doctor can help you find out if you are taking medicines that may make you more sensitive to sunlight. (See “Who should not use Retin-A MICRO®?” And “What should I avoid while using Retin-A MICRO®?”)

What is Retin-A MICRO®?

Retin-A MICRO® is a prescription medicine that you put on your skin to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples.

Who should not use Retin-A MICRO®?

Do not use Retin-A MICRO® if:

• you are sunburned. Do not use Retin-A MICRO® until your skin has fully recovered.
• you have eczema or other skin conditions. Retin-A MICRO® can cause severe irritation if used on eczema.
• you are allergic to any of the ingredients in Retin-A MICRO®.

The active ingredient is tretinoin. See the list of other ingredients at the end of this leaflet.

Tell your doctor before using Retin-A-Micro® if

• you are pregnant, planning to become pregnant, or may be pregnant.
• you are breast feeding. We do not know if Retin-A-MICRO® can pass through your milk to the baby.
• you are using any other medicines to treat your acne. Do not use any other medicines unless they are recommended by your doctor. Other acne medicines used with Retin-A MICRO® may make your face more likely to be dry and red and cause it to peel.
• you are taking medicines for other health conditions. Some medicines may make your skin more sensitive to sunlight. Tell your doctor about all medicines that you are taking. (See “Who should not use Retin-A MICRO®?” And “What should I avoid while using Retin-A MICRO®?”)

How should I use Retin-A MICRO®?

Wash your skin with mild, non-medicated soap and dry your skin gently. Apply Retin-A MICRO® once a day in the evening, or as directed by your doctor.

Squeeze a small amount of Retin-A MICRO® (about the size of a pea) on your fingertip. Dab Retin-A MICRO® on your forehead, chin and both cheeks, Smooth Retin-A MICRO® gently into your skin.

Do not put Retin-A MICRO®, near your mouth, eyes, or open sores, or on the corners of your nose. Spread Retin-A MICRO® away from these areas when putting Retin-A MICRO®on your skin.

Do not use more Retin-A MICRO® than your doctor has prescribed. Do not use RetinA MICRO® more often than your doctor has told you. Too much Retin-A MICRO® may irritate or increase the irritation of your skin, and will not give faster or better results.

You can use a facial cream or lotion each morning after washing your face. It should contain a sun protection factor (SPF) of 15 or higher. Follow your doctor's advice because you need to use a cream or lotion that will not make your acne worse. You may use cosmetics with Retin-A MICRO®. However, clean your face before using cosmetics and remove cosmetics from your skin before using Retin-A MICRO®. Talk to your doctor about recommended cosmetics.

You may not see improvement right away. Retin-A MICRO may work better for some patients than for others. Keep using Retin-A MICRO even after your acne improves. You may notice some results after two weeks, but more than seven weeks of using Retin-A MICRO® are needed before you see the full benefit.

Early in therapy, you may notice new pimples. At this stage, it is important to continue using Retin-A MICRO®.

Once your acne is under control you should continue regular application of Retin-A MICRO® until your doctor instructs otherwise.

What should I avoid while using Retin-A MICRO®?

Spend as little time as possible in the sun. Use a daily sunscreen with a SPF 15 rating or higher, sun protective clothing, and a wide brimmed hat to protect you from sunlight. When outside, even on hazy days, areas treated with Retin-A MICRO®, should be protected. Do not use sunlamps. Retin-A MICRO® may make you get sunburned more easily. If you do get sunburned, stop using Retin-A MICRO® until your skin is completely back to normal. Talk to your doctor about how to protect your skin if you must be in sunlight a lot.

Avoid cold weather and wind as much as possible, and use clothing to protect you from the weather. Skin treated with Retin-A MICRO® may dry out or get windburned more easily.

Avoid skin products that may dry or irritate your skin. Such skin products are those that contain astringents, alcohol, or spices and include certain medicated soaps, shampoos and hair permanent solutions. Avoid contact with the peel of limes. Your skin may become very dry, red, swollen, blistered, or crusted with these products. If you get severe skin irritation or skin irritation that will not go away, stop using Retin-A MICRO®and call your doctor. You should talk to your doctor about the use of all skin care products while using Retin-A MICRO®.

Avoid washing your face too often and do not scrub your face hard when washing it. Use a mild, non-medicated soap and wash gently and pat dry.

Talk to your doctor about using other acne medicines while using Retin-A MICRO®as they could cause redness or peeling.

What are the possible side effects of Retin-A MICRO®?

A brief feeling of warmth or stinging may be normal when you apply Retin-A MICRO®.

The most common side effect with Retin-A MICRO® is skin irritation. This can include skin redness, burning, stinging, itching, dryness, and peeling. Some of these side effects may go away or bother you less after you have used Retin-A MICRO® for a few weeks. Tell your doctor if these side effects become a problem. Your doctor may change your dose of Retin-A MICRO®. However, the effectiveness of Retin-A MICRO® when used less than once a day has not been proven.

There may be some mild discomfort or peeling during the early weeks of treatment. Some patients also notice that their skin begins to take on a blush. These reactions happen to about half of the people using Retin-A MICRO. If this happens to you, it is just your skin getting used to Retin-A MICRO® . This usually improves by 4 weeks after starting treatment. These reactions can usually be lessened by following instructions carefully. If the discomfort is a problem, talk to your doctor.

Call your doctor right away if your face becomes very dry, red, swollen, or blistered. Your doctor may ask you to stop using Retin-A MICRO®for a while, change the amount of Retin-A MICRO®you are using, or change the times that you use Retin-A MICRO®.

These are not all the side effects possible with Retin-A MICRO®. For more information, ask your doctor or pharmacist.

General Information about Retin-A MICRO®

This medicine is for your use only. Do not allow anyone else to use this medicine. Medicines are sometimes prescribed for conditions not mentioned in patient information leaflets. Do not use Retin-A MICRO® for a condition for which it was not prescribed by your doctor.

What are the ingredients of Retin-A MICRO®?

The active ingredient is tretinoin. The inactive ingredients are purified water, carbomer 974P (0.04% formulation), carbomer 934P (0.1% formulation), glycerin, disodium EDTA, propylene glycol, sorbic acid, PPG-20 methyl glucose ether distearate, cyclomethicone and dimethicone copolyol, benzyl alcohol, trolamine, and butylated hydroxytoluene.

How do I store Retin-A Micro®?

Retin-A Micro should be stored at room temperature,15 °-25°C (59°-77°F).

Where can I get more information about Retin-A Micro?

You can ask your doctor or pharmacist for the information about Retin-A MICRO® that is written for health professionals. You can also contact ORTHO DERMATOLOGICAL by calling their toll-free number: 800-426-7762. Call between 9:00 a.m. and 3:00 p.m. Eastern Time, Monday through Friday

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