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LUSTRA | Lustra [Taro Pharmaceuticals U.S.A., Inc.] | BioPortfolio

12:45 EST 27th January 2019 | BioPortfolio
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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

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 pK of 9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is CHO; molecular weight 110.1. The structural formula is:

Hydroquinone USP 4%.

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.

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.

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) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation which may be prevented by the broad spectrum sunscreen agents contained in LUSTRA-AF.

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.

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.

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.

SEE WARNINGS

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.

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.

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

LUSTRA-AF (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
SIZE NDC NUMBER
2 oz tube (56.8 g) 51672-1327-3

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

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 ofTaro Pharmaceuticals U.S.A., Inc.

Revised: October, 2011

PK-4967-3111

NDC 51672-1326-3

RX ONLY

LUSTRA

(HYDROQUINONE CREAM USP, 4%)

NET WT. 2 oz (56.8 g)

NDC 51672-1327-3

RX ONLY

LUSTRA-AF

(HYDROQUINONE CREAM USP, 4%)

NET WT. 2 oz (56.8 g)

Manufacturer

Taro Pharmaceuticals U.S.A., Inc.

Active Ingredients

Source

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