Label: LUSTRA- hydroquinone cream
LUSTRA-AF- hydroquinone cream

  • NDC Code(s): 51672-1326-3, 51672-1326-8, 51672-1327-3
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/12

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  • SPL UNCLASSIFIED SECTION

    LUSTRA®

    (HYDROQUINONE CREAM USP, 4%)

    The Complete Treatment for Dyschromia

    LUSTRA-AF®

    (HYDROQUINONE CREAM USP, 4%)

    The Complete Treatment for Dyschromia

    Rx Only

    FOR EXTERNAL USE ONLY

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  • I. DESCRIPTION

    Hydroquinone is 1,4-benzenediol. Hydroquinone is structurally related to monobenzone. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol and has a pKa of 9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight 110.1. The structural formula is:

    Chemical Structure

    C6H6O2

    CONTENTS

    ACTIVE INGREDIENT

    Hydroquinone USP 4%.

    OTHER INGREDIENTS (LUSTRA®)

    Alcohol, benzyl alcohol, butylated hydroxytoluene, carbomer 940, cetearyl alcohol (and) ceteareth-20, cetyl alcohol, cyclopentasiloxane (and) polysilicone-11, dimethiconol, disodium EDTA, fragrance, glycerin, glyceryl stearate (and) PEG-100 stearate, glycolic acid, hydrogenated lecithin, linoleic acid, magnesium 1-ascorbyl phosphate, phenoxyethanol, phenyl trimethicone, polyacrylamide (and) C13-14 isoparaffin (and) laureth 7, purified water, sodium metabisulfite, sodium citrate dihydrate, vitamin E acetate, vitamin E alcohol, triethanolamine.

    OTHER INGREDIENTS (LUSTRA-AF®)

    Alcohol, avobenzone, benzyl alcohol, butylated hydroxytoluene, carbomer 940, cetearyl alcohol (and) ceteareth-20, cetyl alcohol, cyclopentasiloxane (and) polysilicone-11, dimethiconol, disodium EDTA, fragrance, glycerin, glyceryl stearate (and) PEG-100 stearate, glycolic acid, hydrogenated lecithin, linoleic acid, magnesium 1-ascorbyl phosphate, octinoxate, phenoxyethanol, phenyl trimethicone, polyacrylamide (and) C13-14 isoparaffin (and) laureth 7, purified water, sodium metabisulfite, sodium citrate dihydrate, vitamin E acetate, vitamin E alcohol, triethanolamine.

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  • II. CLINICAL PHARMACOLOGY

    Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3-(3,4-dihydroxyphenyl) alanine (dopa)1 and suppression of other melanocyte metabolic processes.2 Exposure to sunlight or ultraviolet light will cause repigmentation which may be prevented by the broad spectrum sunscreen agents contained in LUSTRA-AF®.3

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  • III. INDICATIONS AND USAGE

    LUSTRA® and LUSTRA-AF® are indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.

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  • IV. DOSAGE AND ADMINISTRATION

    LUSTRA® or LUSTRA-AF® should be applied to the affected areas twice daily, morning and before bedtime, or as directed by a physician. During and after the use of LUSTRA® sun exposure should be limited, and a sunscreen agent or sun-protective clothing should be used to cover the treated areas, to prevent repigmentation. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

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  • V. CONTRAINDICATIONS

    LUSTRA® and LUSTRA-AF® are contraindicated in any patient that has 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.

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  • VI. WARNINGS

    A.
    CAUTION: Hydroquinone is a depigmenting agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
     
    B.
    Test for skin sensitivity before using LUSTRA ® or LUSTRA-AF ® by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching, vesicle formation, or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided.

    If no lightening effect is noted after two months of treatment, use of LUSTRA ® or LUSTRA-AF ® should be discontinued. LUSTRA-AF ® is formulated for use as a treatment for dyschromia and should not be used for the prevention of sunburn.
     
    C.
    Sunscreen use is an essential aspect of hydroquinone therapy, because even minimal sunlight sustains melanocytic activity. 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 sunblocking or sunscreening agents in LUSTRA ®. The sunscreens in LUSTRA-AF ® provide the necessary sun protection during therapy. During and after the use of LUSTRA-AF ®, sun exposure should be limited or sun-protective clothing should be used to cover the treated areas to prevent repigmentation.
     
    D.
    Keep this and all medications out of the reach of children. In case of accidental ingestion, 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.
     
    F.
    On rare occasions, a gradual blue-black darkening of the skin may occur. In which case, use of LUSTRA ® or LUSTRA-AF ® should be discontinued and a physician contacted immediately.
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  • VII. PRECAUTIONS

    SEE WARNINGS

    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.
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  • VIII. ADVERSE REACTIONS

    No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately.

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  • IX. OVERDOSAGE

    There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

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  • X. HOW SUPPLIED

    LUSTRA® (Hydroquinone Cream USP, 4%) is available as follows:

    SIZE NDC NUMBER
    1/8 oz tube (3.5 g) Physicians Sample 51672-1326-8
    2 oz tube (56.8 g) 51672-1326-3

    LUSTRA-AF® (Hydroquinone Cream USP, 4%) is available as follows:

    SIZE NDC NUMBER
    2 oz tube (56.8 g) 51672-1327-3
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  • REFERENCES

    1. Denton, C., A.B. Lerner, and T.B. Fitzpatrick. "Inhibition of Melanin Formation by Chemical Agents." Journal of Investigative Dermatology. 1952; 18:119-135.
    2. Jimbow, K., H. Obata, M. Pathak, and T.B. Fitzpatrick. "Mechanism of Depigmentation by Hydroquinone." Journal of Investigative Dermatology. 1974; 62:436-449.
    3. Parrish, J.A., R.R. Anderson, F. Urbach, and D. Pitts. UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet. Plenum Press, New York and London, 1978, p.151.
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  • STORAGE AND HANDLING

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

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  • SPL UNCLASSIFIED SECTION

    Covered by US Patent 5,932,612.

    Mfd. by: Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1

    Dist. by: TaroPharma
    a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

    Made in Canada

    LUSTRA®, LUSTRA-AF® and TaroPharma® are registered trademarks of
    Taro Pharmaceuticals U.S.A., Inc.

    Revised: October, 2011

    PK-4967-3
    111

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  • PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton

    NDC 51672-1326-3

    RX ONLY

    LUSTRA®

    (HYDROQUINONE CREAM USP, 4%)

    NET WT. 2 oz (56.8 g)

    PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton
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  • PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton

    NDC 51672-1327-3

    RX ONLY

    LUSTRA-AF®

    (HYDROQUINONE CREAM USP, 4%)

    NET WT. 2 oz (56.8 g)

    PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    LUSTRA 
    hydroquinone cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-1326
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    benzyl alcohol  
    butylated hydroxytoluene  
    carbomer homopolymer type c  
    cetostearyl alcohol  
    polyoxyl 20 cetostearyl ether  
    cetyl alcohol  
    cyclomethicone 5  
    edetate disodium  
    glycerin  
    glyceryl monostearate  
    PEG-100 stearate  
    glycolic acid  
    linoleic acid  
    phenoxyethanol  
    phenyl trimethicone  
    C13-14 isoparaffin  
    laureth-7  
    water  
    sodium metabisulfite  
    trisodium citrate dihydrate  
    alpha-tocopherol acetate  
    trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-1326-8 1 in 1 CARTON
    1 3.5 g in 1 TUBE
    2 NDC:51672-1326-3 1 in 1 CARTON
    2 56.8 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/20/2005
    LUSTRA-AF 
    hydroquinone cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-1327
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    avobenzone  
    benzyl alcohol  
    butylated hydroxytoluene  
    carbomer homopolymer type c  
    cetostearyl alcohol  
    polyoxyl 20 cetostearyl ether  
    cetyl alcohol  
    cyclomethicone 5  
    edetate disodium  
    glycerin  
    glyceryl monostearate  
    PEG-100 stearate  
    glycolic acid  
    linoleic acid  
    octinoxate  
    phenoxyethanol  
    phenyl trimethicone  
    C13-14 isoparaffin  
    laureth-7  
    water  
    sodium metabisulfite  
    trisodium citrate dihydrate  
    alpha-tocopherol acetate  
    trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-1327-3 1 in 1 CARTON
    1 56.8 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/20/2005
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-1326, 51672-1327)
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