Lustra

Lustra

Lustra Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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.

Lustra Manufacturers


  • Taro Pharmaceuticals U.s.a., Inc.
    Lustra (Hydroquinone) Cream Lustra-af (Hydroquinone) Cream [Taro Pharmaceuticals U.s.a., Inc.]

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