Fluocinolone-Hydroquinone-Tretinoin 0.01 %-4 %-0.05 % Topical Cream

Question 1

How to use this information

Answer

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective or appropriate for you. This information is not individual medical advice and does not substitute for the advice of a medical provider. If you have any questions, go to your patient dashboard and request a callback for complete information about this product and your specific health needs.

Question 2

Medication name:

Answer

FLUOCINOLONE/TRETINOIN/HYDROQUINONE - TOPICAL

COMMON BRAND NAME(S): Tri-Luma

Question 3

What you should know about Fluocinolone/Tretinoin/Hydroquinone

Answer

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. This disrupts melanin production, which can help with hyperpigmentation.
- Tretinoin is a retinoid that promotes skin cell growth.
- 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 (such as sunlight, estrogen-type birth control hormones) may cause it to return.

Question 4

How to use Fluocinolone/Tretinoin/Hydroquinone

Answer

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 medical provider 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 request a callback from your medical provider through your patient dashboard. 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, such as Cetaphil. 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 medical provider.
Rub the medication into the skin gently and completely. Do not bandage, cover or wrap the area unless directed to do so by your medical provider.
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.
It may take up to 4 weeks to notice significant improvement. However, this medication is not recommended for long-term use (more than 8 weeks) without stopping the medication for short periods. Tell your medical provider if your condition lasts or gets worse after 4 weeks of treatment.

Question 5

Potential side effects

Answer

Mild burning, stinging, redness, dryness or acne may occur. If any of these effects last or get worse, go to your patient dashboard and request a medical provider callback for assistance.
Remember that this medication has been prescribed because your medical provider 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.
Request a medical provider callback right away if you have any serious side effects, including: 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.
Contact your medical provider right away if any of the following side effects occur: unusual/extreme tiredness, weight changes, headache, swelling ankles/feet, increased thirst/urination, vision problems.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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 other effects not listed above, request a callback for medical advice. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Question 6

Precautions to be aware of

Answer

Before using Fluocinolone/Tretinoin/Hydroquinone, tell your medical provider or pharmacist if you are allergic to it; or to other corticosteroids (such as 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 medical provider or pharmacist your medical history, especially of: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (such as 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 medical provider 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. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your medical provider or dentist that you are using this medication or have used this medication within the past few months.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Talk with your OB/GYN if you are pregnant or planning to become pregnant.
It is not known whether these drugs pass into breast milk when applied to the skin. Consult your OB/GYN before breast-feeding. Avoid skin-to-skin contact with your infant in areas where this product has been used.

Question 7

Drug interactions

Answer

Drug interactions may change how your medications work or increase your risk for serious side effects.
This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your medical provider and pharmacist.
Do not start, stop or change the dosage of any medicines without your medical provider's approval.
Some products that may interact with this drug are:
- Other medicated skin products (such as soaps, cleansers, skin medications, skin-drying cosmetics)
- Hormone-based birth control products (such as birth control pills, hormone implants).

Question 8

What to do in the event of an overdose

Answer

This medicine may be harmful if swallowed.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. If symptoms from taking this medication are less severe, call your local poison control center at 1-800-222-1222 right away.

Question 9

Additional notes

Answer

Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your medical provider. A different medication may be necessary in that case.
Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your medical provider for more details.
Because this product contains a corticosteroid, inform all your medical providers that you use or have used this product.

Question 10

What to do if you miss a dose

Answer

If you miss a dose, use it as soon as you remember.
If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Question 11

How to store this medication

Answer

Store in the refrigerator. Do not freeze.
Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.