TRI-LUMA (Page 4 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

TRI-LUMA Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30.

Storage: Keep tightly closed. Store in a refrigerator, 2° — 8°C (36° — 46°F). Protect from freezing.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Inform patients of the following:

  • Advise patients to change to non-hormonal forms of birth control, if hormonal methods are used.
  • Use TRI-LUMA Cream as directed by the health care provider and do not use TRI-LUMA Cream for any disorder other than that for which it is prescribed.
  • Avoid exposure to sunlight, sunlamp, or ultraviolet light. Patients who are consistently exposed to sunlight or skin irritants either through their work environment or habits should exercise particular caution. Use sunscreen and protective covering (such as the use of a hat) over the treated areas. Sunscreen use is an essential aspect of melasma therapy, as even minimal sunlight sustains melanocytic activity.
  • Weather extremes, such as heat or cold, may be irritating to patients treated with TRI-LUMA Cream. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing.
  • Keep TRI-LUMA Cream away from the eyes, nose, angles of the mouth, or open wounds because these areas are more sensitive to the irritant effect. If local irritation persists or becomes severe, discontinue application of the medication and consult your health care provider. Seek medical attention if you experience allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritation of the mucous membranes of the eyes, nose, and mouth.
  • If the medication is applied excessively, marked redness, peeling, or discomfort may occur.
  • Wash your hands after each application.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, TX 76177 USA


Manufactured by:

Hill Dermaceuticals, Inc.

Sanford, FL 32773 USA

P51400-1

PATIENT INFORMATION

TRI-LUMA® (try-LOOM-ah)

(fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%)

Cream

Important information: TRI-LUMA Cream is for use on skin only. Do not use TRI-LUMA Cream in your mouth, eyes, or vagina.

What is the most important information I should know about TRI-LUMA Cream?

TRI-LUMA Cream may cause birth defects or death of the baby if used during pregnancy. The risk of birth defects or death of the baby may be greater if TRI-LUMA Cream is used during the first trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

If you become pregnant while using TRI-LUMA Cream, tell your doctor right away.

What is TRI-LUMA Cream?

TRI-LUMA Cream is a prescription medicine used for the short-term treatment of moderate to severe melasma of the face, in combination with sun avoidance and the use of sunscreens.

TRI-LUMA Cream is not for continuous treatment of melasma.

It is not known if TRI-LUMA Cream is safe and effective in children.

It is not known if TRI-LUMA Cream is safe and effective in people with dark brown to black skin color.

It is not known if TRI-LUMA Cream is safe and effective in the treatment of dark spots (hyperpigmentation) of the skin caused by conditions other than melasma of the face.

It is not known if TRI-LUMA Cream is safe and effective in females who are pregnant or who are breastfeeding. See “What is the most important information I should know about TRI-LUMA Cream? and What should I tell my doctor before using TRI-LUMA Cream?”

Who should not use TRI-LUMA Cream?

Do not use TRI-LUMA Cream if you are allergic to it or any of the ingredients in TRI-LUMA Cream. See the end of this leaflet for a complete list of ingredients in TRI-LUMA Cream.

What should I tell my doctor before using TRI-LUMA Cream?

Before you use TRI-LUMA Cream, tell your doctor if you:

  • are allergic to sulfites
  • have any other medical conditions
  • are pregnant or plan to become pregnant. See What is the most important information I should know about TRI-LUMA Cream?”
  • are breastfeeding or plan to breastfeed. It is not known if TRI-LUMA Cream passes into your breast milk. You should avoid skin-to-skin contact between areas treated with TRI-LUMA Cream and your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements and skin products that you use.

How should I use TRI-LUMA Cream?

  • Use TRI-LUMA Cream exactly as your doctor tells you to use it.
  • Before you apply TRI-LUMA Cream, gently wash your face with a mild cleanser. Rinse your face and pat your skin dry.
  • Apply TRI-LUMA Cream 1 time a day, at least 30 minutes before bedtime.
  • Apply a thin layer of TRI-LUMA Cream to the affected skin areas. Include about 1/2 inch of normal skin surrounding the affected area.
  • Gently rub TRI-LUMA Cream evenly into your skin.
  • Do not get TRI-LUMA Cream near the corners of your mouth, your nose, your eyes, or open wounds.
  • Do not bandage or cover the treated skin after applying TRI-LUMA Cream.
  • You may use moisturizers and cosmetics during the day.
  • Wash your hands after applying TRI-LUMA Cream.

What should I avoid while using TRI-LUMA Cream?

  • You should avoid sunlight, sunlamps, tanning beds, and ultraviolet light during treatment with TRI-LUMA Cream.

    • Use a sunscreen with SPF (sun protection factor) of 30 or more. If you have to be in the sunlight, wear a wide-brimmed hat or other protective clothing to cover the treated areas.
    • Melasma can get worse with even a small amount of sunlight. You should continue to avoid sunlight, use sunscreen, and wear protective clothing after treatment with TRI-LUMA Cream.

  • Females should avoid the use of hormonal forms of birth control. Hormonal birth control methods can cause your melasma to become worse. Talk to your doctor about other birth control options.
  • Heat and cold weather may irritate skin treated with TRI-LUMA. Talk with your doctor about ways to manage skin irritation.

What are the possible side effects of TRI-LUMA Cream?

TRI-LUMA Cream may cause serious side effects, including:

  • allergic reactions. TRI-LUMA Cream may cause allergic reactions that can be life threatening. Stop using TRI-LUMA Cream and call your doctor to get medical help right away if you get any of the following symptoms:
    • swelling of your face, eyes, lips, tongue, or throat
    • trouble breathing
    • severe itching
    • skin rash or hives
  • change in skin color. One of the medicines in TRI-LUMA Cream can cause a blue-black darkening of your skin. Stop using TRI-LUMA Cream and tell your doctor if you develop a blue-black darkening of your skin.

• TRI-LUMA Cream can pass through your skin. Too much TRI-LUMA Cream passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.

  • skin irritation. Stop using TRI-LUMA Cream and call your doctor if you have:
    • blistering or crusting of your skin
    • severe burning
    • swelling of your skin
    • irritation of your eyes, nose, or mouth

The most common side effects of TRI-LUMA Cream include:

  • redness
  • peeling
  • burning
  • dryness
  • itching
  • acne

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRI-LUMA Cream. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

How should I store TRI-LUMA Cream?

  • Store TRI-LUMA Cream in a refrigerator, between 36°F to 46°F (2°C to 8 °C).
  • Keep TRI-LUMA Cream tube tightly closed.
  • Do not freeze TRI-LUMA Cream.

General information about the safe and effective use of TRI-LUMA Cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TRI-LUMA Cream for a condition for which it was not prescribed. Do not give TRI-LUMA Cream to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TRI-LUMA Cream that is written for health professionals.

What are the ingredients in TRI-LUMA Cream?

Active ingredients: fluocinolone acetonide, hydroquinone, and tretinoin

Inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol

This Patient Information has been approved by the U.S. Food and Drug Administration.


Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, TX 76177 USA


Manufactured by:

Hill Dermaceuticals, Inc.

Sanford, FL 32773 USAP51400-1

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