The LUSTRA Product Family
Important Information about LUSTRA-ULTRA (hydroquinone USP 4%), LUSTRA-AF® (hydroquinone USP 4%), and LUSTRA® (hydroquinone USP 4%)



CAUTION:
Federal (USA) law prohibits dispensing without a prescription. Check with your physician to see if LUSTRA-ULTRA, LUSTRA-AF, and LUSTRA is right for you.

FOR EXTERNAL USE ONLY:

  1. INDICATIONS AND USAGE:
    LUSTRA-ULTRA, LUSTRA-AF, and LUSTRA are indicated for the gradual treatment of skin discoloration resulting from over-exposure to the sun and the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.


  2. HOW TO USE: Apply LUSTRA-ULTRA, LUSTRA-AF, or LUSTRA to the affected areas twice daily—morning and before bedtime—or as directed by a physician. Limit sun exposure, apply and use a sunscreen or sun-protective clothing to cover the treated areas to prevent repigmentation. If using LUSTRA-ULTRA or LUSTRA-AF, after completing treatment, apply a sunscreen to treated areas or wear sun-protective clothing to prevent repigmentation.

    There is no recommended dosage for patients under 12 years of age except under the advice and supervision of a physician.

    Hydroquinone will only affect the skin area that is treated and has never been reported to affect parts of the body distant from the site of application. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience temporary skin reddening and a mild burning sensation. 

  1. THE LUSTRA FAMILY OF PRODUCTS  ARE NOT FOR EVERYONE:
    Do not use LUSTRA-ULTRA, LUSTRA-AF, or LUSTRA if you have a prior history of hypersensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or on children (12 years and under) has not been established.

  2. AS WITH ALL PRESCRIPTION PRODUCTS, USE LUSTRA-ULTRA, LUSTRA-AF, and LUSTRA CAREFULLY:

    A. CAUTION: Hydroquinone, the active ingredient in LUSTRA-ULTRA, LUSTRA-AF, and LUSTRA, treats skin discoloration. It is a depigmenting agent that lightens areas of the skin that are darker than the surrounding skin, and it may produce unwanted cosmetic effects if not used as directed.

    B. Test for skin sensitivity before using LUSTRA-ULTRA, LUSTRA-AF, or LUSTRA by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness does not necessarily mean treatment should be stopped. Where there is itching, blistering, or excessive swelling and redness, further treatment is not advised; however, it is recommended that you contact your physician. Contact with the eyes should be avoided. If no lightening effect is noted after two months of treatment, LUSTRA-ULTRA, LUSTRA-AF, and LUSTRA should be discontinued.

    C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight encourages the skin to produce more color. During treatment and maintenance therapy, sun exposure should be avoided on treated skin by application of a broad-spectrum sunscreen (SPF 15 or greater) or by use of protective clothing to prevent repigmentation. Although LUSTRA has an antioxidant system in its vehicle, there are no sun blocking or sun screening agents in LUSTRA.

    D. Keep this and all medications out of the reach of children. In case of accidental swallowing, contact a physician or a poison control center immediately.

    E. WARNING: Contains sodium metabisulfite, a sulfite which may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.

  3. PRECAUTIONS: Important Notice
    A.
    Pregnancy Category C: Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or can affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only where clearly indicated.

    B. Nursing mothers: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when hydroquinone is used by a nursing mother.

    C. Pediatric usage: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

  4. ADVERSE REACTIONS: 
    Use of hydroquinone on the skin has never resulted in a report of a reaction or effect on another part of the body distant from the site of application. If skin hypersensitivity (an allergy localized to the skin area that was treated) occurs, discontinue use of LUSTRA-ULTRA, LUSTRA-AF, or LUSTRA and notify your physician immediately.

    LUSTRA-ULTRA, LUSTRA-AF, and LUSTRA should be stored at controlled room temperature: 15°-25°C (59°-77°F).


Talk to your dermatologist to see if one of the LUSTRA Family of products is right for you.

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LUSTRA-ULTRA (hydroquinone USP 4%), LUSTRA-AF® (hydroquinone USP 4%), and LUSTRA® (hydroquinone USP 4%) are trademarks of MEDICIS Pharmaceutical Corporation, used under license by Taro Pharmaceuticals U.S.A., Inc.
TaroPharma® is a trademark of Taro Pharmaceuticals U.S.A., Inc.
©2007 Taro Pharmaceuticals U.S.A., Inc. All rights reserved.