Trifarotene topical (for use on skin) is a compound similar to vitamin A. It helps the skin renew itself and may improve the appearance and texture of skin.

Trifarotene topical (for the skin) is used to treat acne vulgaris in adults and children at least 9 years old.

Trifarotene topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or on sunburns, abrasions, or irritated skin.

Also avoid using this medicine on areas of eczema. Wait until these areas have fully healed before using trifarotene topical.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Trifarotene topical is usually applied once daily in the evening. Follow your doctor's instructions.

Wash and pat dry the skin before using this medicine. Apply a thin layer of cream to the affected areas once daily in the evening.

Trifarotene topical can irritate your skin, and this may be most noticeable during the first 4 weeks of treatment. Irritation should become less severe as you continue using the medicine.

While using trifarotene topical, use a moisturizing cream or lotion to help lessen skin irritation.

Store at room temperature away from heat. Keep the tube tightly closed when not in use.

Usual Adult Dose for Acne:

Apply a thin layer to the affected areas once a day (in the evening) on clean and dry skin.

Comments:
-One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, chin).
-Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders, chest); if needed, use 1 additional pump actuation for acne on the middle and lower back.
-Moisturizer should be used as often as needed from the start of therapy.

Use: For the topical treatment of acne vulgaris

Usual Pediatric Dose for Acne:

9 years or older: Apply a thin layer to the affected areas once a day (in the evening) on clean and dry skin.

Comments:
-One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, chin).
-Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders, chest); if needed, use 1 additional pump actuation for acne on the middle and lower back.
-Moisturizer should be used as often as needed from the start of therapy.

Use: For the topical treatment of acne vulgaris in patients 9 years of age and older.

Tell your doctor if you have ever had eczema or other skin problems.

Tell your doctor if you are pregnant or breastfeeding.

If you breastfeed, apply trifarotene topical to the smallest possible skin area and use the medicine for the shortest amount of time needed to treat your acne. If you apply trifarotene topical to your chest, avoid areas that may come into contact with the baby's mouth.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of trifarotene is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Trifarotene could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid getting trifarotene topical in your eyes and mouth or on your lips, nose, or the creases beside your nose.

Avoid using skin products that can cause irritation, such as harsh soaps, cleansers, hair removers or waxes, or products that contain alcohol or can dry the skin.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Trifarotene topical may cause serious side effects. Stop using trifarotene topical and call your doctor at once if you have:

• severe skin irritation (burning, stinging, scaling) after applying the medicine; or

• severe skin redness or dryness.

Common side effects of trifarotene topical may include:

• itching or other skin irritation; or

• sunburn.

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.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.