Fluocinolone/Hydroquinone/Tretinoin Topical

Fluocinolone is a steroid that reduces inflammation or swelling.

Hydroquinone is a skin bleaching agent.

Tretinoin is a form of vitamin A that helps the skin to renew itself more quickly.

Fluocinolone, hydroquinone, and tretinoin topical (for use on the skin) is a combination medicine used to treat melasma (dark skin patches) on the face.

Fluocinolone, hydroquinone, and tretinoin topical may also be used for purposes not listed in this medication guide.

Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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.

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.

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.

This combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness.

This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (e.g., sunlight, estrogen-type birth control hormones) may cause it to return.

How to use Fluocinolone-Hydroq.-Tretinoin Cream

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin.

Before using, gently wash your face and neck with a mild soapless cleanser. Rinse and pat dry the skin.

Apply a thin layer of medication to the affected area, including about 1/2 inch (1.5 centimeters) of normal-appearing skin around the affected area, once daily 30 minutes before bedtime or as directed by your doctor. Rub the medication into the skin gently and completely. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.

This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen of SPF 30 or greater and wear protective clothing on the treated areas of skin when outdoors, even on cloudy or hazy days.

If you experience dry skin from using this product, you may use a skin moisturizer in the morning after washing your face. You may also use a moisturizer and cosmetics during the day while using this medication.

Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water. If severe irritation occurs, seek medical attention promptly.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each night.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

It may take up to 4 weeks to notice significant improvement. However, this medication is not recommended for long-term use (e.g., longer than 8 weeks) without stopping the medication for short periods. Inform your doctor if your condition persists or worsens after 4 weeks of treatment.

See also How to Use.

Mild burning, stinging, redness, dryness, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: blistering, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), "hair bumps" (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using fluocinolone/tretinoin/hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (e.g., eczema, psoriasis).

Too much bleaching of the skin might occur in some cases, resulting in an undesirable cosmetic effect in those with darker skin. Consult your doctor or pharmacist for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Children may be more sensitive to the effects of too much corticosteroid medication. Though it is very unlikely to occur with corticosteroids applied to the skin, this medication may temporarily slow down a child's rate of growth if used for long periods. However, it will probably not affect final adult height. Monitor your child's height periodically.

This medication is not recommended for use during pregnancy. One medication in this product (tretinoin) has caused harm to an unborn baby when taken by mouth. Discuss the risks and benefits with your doctor.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

It is not known whether these drugs pass into breast milk when applied to the skin. Consult your doctor before breast-feeding. Avoid skin-to-skin contact with your infant in areas where this product has been used.