Atralin (tretinoin) Gel, 0.05%
For Skin Use Only
Important: Not for mouth, eye, or vaginal use.
Read the patient information that comes with Atralin Gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your acne or treatment.

What is Atralin Gel?

Atralin Gel is a prescription medicine used on the skin to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. Atralin Gel may not be right for you. Tell your doctor about all of your health conditions, including if you:

• are allergic to fish
• have a skin condition called eczema
• are pregnant or planning to become pregnant. Atralin Gel may harm your fetus (unborn baby).
• are breastfeeding. It is not known if Atralin Gel passes into breast milk and to your baby.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines can make your skin more sensitive to sunlight. Know the medicines you take. Keep a list of your medicines with you to show your doctor. Your doctor will decide if you can use Atralin Gel with your other medicines.

Tell your doctor about all of the skin products you use. Your doctor will tell you which skin products you can use with Atralin Gel. You should avoid using skin products that can dry or irritate your skin because skin dryness and irritation are increased with Atralin Gel. Skin products that can dry and irritate your skin include:

• products that contain alcohol, astringents, or spices
• acne medicines that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid
• medicated soap or skin cleansers

How should I use Atralin Gel?

• Wash your skin with mild, non-medicated soap and dry your skin gently. Apply Atralin once a day before bedtime.
• Squeeze a small amount of Atralin Gel (about the size of a pea) on your fingertip. Apply Atralin Gel, using a thin layer to cover the entire affected area. Smooth Atralin Gel gently into your skin.
• Do not put Atralin Gel, near your mouth, eyes, on the corners of your nose, or on open sores. Spread Atralin away from these areas when putting Atralin on your skin.
• Do not use more Atralin Gel than your doctor has prescribed. Do not use Atralin Gel more often than your doctor has told you. Too much Atralin Gel 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 of SPF 15 or higher each morning after washing your face. 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 Atralin Gel. However, clean your face before using cosmetics and remove cosmetics from your skin before using Atralin Gel. Talk to your doctor about recommended cosmetics.
• You may not see improvement right away. Atralin Gel may work better for some patients than for others.
• Once your acne is under control you should continue to use Atralin Gel as your doctor instructs you to do.

What should I avoid while using Atralin Gel?

• Spend as little time as possible in the sun. Use a daily sunscreen with a SPF 15 rating or higher, protective clothing, and a wide brimmed hat to protect you from sunlight. When outside, even on hazy days, areas treated with Atralin Gel should be protected. Do not use sunlamps or tanning beds. Atralin Gel may make you get sunburned more easily. If you do get sunburned, stop using Atralin Gel 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 Atralin Gel may dry out or get windburned more easily.

What are the possible side effects of Atralin Gel?

The most common side effect with Atralin Gel is skin irritation. This can include dry skin, burning, redness, excessive flaking or peeling. Some of these side effects may go away or bother you less after you have used Atralin Gel for a few weeks. Tell your doctor if these side effects become a problem. Your doctor may ask you to stop using Atralin Gel for a while, change the amount of Atralin Gel you are using, or have you use Atralin Gel less than once a day. These are not all the side effects possible with Atralin Gel. For more information, ask your doctor or pharmacist.

How do I store Atralin Gel?

Store Atralin Gel at controlled room temperature 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F). Protect from freezing.

Keep Atralin Gel and all medicines out of the reach of children.

General Information about Atralin Gel

Do not allow anyone else to use this medicine. Medicines are sometimes prescribed for conditions not mentioned in patient information leaflets. Do not use Atralin Gel for a condition for which it was not prescribed by your doctor. Do not share Atralin Gel with other people, even if they have the same condition you have. It may harm them.

What are the ingredients of Atralin Gel?

Active ingredient: tretinoin
Inactive ingredients: benzyl alcohol, butyl paraben, butylated hydroxytoluene, carbomer 940, ethyl paraben, fish collagen hydrolyzates, glycerin, iso-butyl paraben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine.

For more information about Atralin Gel, talk with your doctor. You can ask your doctor or pharmacist for the information about Atralin Gel that is written for health professionals. You can also contact CORIA Laboratories by calling their toll-free number: 1-800-321-4576.

Indication and Important Safety Information

Atralin Gel is indicated for the topical treatment of acne vulgaris and has not been studied in patients younger than 10 years of age. Tell your doctor about all of your health conditions, including if you are allergic to fish; have a skin condition called eczema; are pregnant or planning to become pregnant; or are breastfeeding. To prevent aggravating the skin, you should protect your skin from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas are recommended when exposure cannot be avoided. Use Atralin Gel with caution if you are allergic to fish; if you begin to itch or you develop hives, contact your healthcare provider. The most common adverse reaction was mild to moderate irritation of the skin, which occurred during the first few weeks of treatment with Atralin Gel.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.