Fluocinolone, hydroquinone, and tretinoin topical

You should not use this medicine if you are allergic to fluocinolone, hydroquinone, or tretinoin.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma; or

• a sulfite allergy.

Using fluocinolone, hydroquinone, and tretinoin topical during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

The pill form of tretinoin is known to cause birth defects. Although your skin does not absorb as much tretinoin as if you were taking the medicine by mouth, it may be best not to use fluocinolone, hydroquinone, and tretinoin topical if you are pregnant. Talk to your doctor first.

Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) can cause melasma to get worse. Ask your doctor about using a non hormonal birth control (condom, diaphragm with spermicide) instead.

It is not known whether fluocinolone, hydroquinone, and tretinoin topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Fluocinolone, hydroquinone, and tretinoin topical is for use only on the skin. If this medicine gets in your eyes or mouth, rinse with water.

Fluocinolone, hydroquinone, and tretinoin topical is usually applied once per day, at least 30 minutes before bedtime. Follow your doctor's instructions.

Gently wash your face with a mild cleanser before applying this medicine. Rinse and pat dry the skin.

Apply a thin film of the medicine only to skin affected by melasma, as well as about 1/2 inch of the surrounding skin. Avoid getting the medicine on your lips or in the creases of your nose.

Do not cover treated skin with a bandage. Bandaging can increase the amount of drug absorbed through your skin and may cause harmful effects.

Wash your hands after applying the medicine.

Fluocinolone, hydroquinone, and tretinoin topical is for short-term use only until you get the desired results. This medicine should not be used on a regular basis to prevent further skin discoloration.

Using use this medicine in larger amounts or applying it more often than prescribed will not make it work any faster, and it may increase side effects.

Fluocinolone, hydroquinone, and tretinoin topical should be used as part of a complete skin care program that includes avoiding sunlight, using an effective sunscreen (minimum SPF of 30), and wearing protective clothing.

Store at room temperature away from moisture and heat.

Do not share this medicine with another person, even if they have the same symptoms you have.

Use the missed dose as soon as you remember, or wait until the next night to apply the medicine. Do not use extra medicine to make up the missed dose.

An overdose of fluocinolone, hydroquinone, and tretinoin topical applied to the skin 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.

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

Stop using this medicine and call your doctor at once if you have:

• darkening or discoloration of treated skin;

• irritation of your eyes, nose, or mouth;

• severe skin redness, itching, peeling, blistering, or crusting;

• severe burning or swelling of the skin; or

• possible signs of absorbing fluocinolone through your skin--worsening tiredness or muscle weakness; loss of appetite, diarrhea; weight loss or weight gain (especially in your face or your upper back and torso); slow wound healing, thinning skin, increased body hair; changes in sexual function; depression, anxiety, feeling irritable.

Common side effects may include:

• acne; or

• mild redness, burning, itching, dryness, or peeling of your skin.

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.