FDA records indicate that there are no current recalls for this drug.
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Hydroquinone Time Release Recall
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Side Effects & Adverse Reactions
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring.
Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
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
Hydroquinone USP, 4% Time Release Cream is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration (such as chloasma, melasma, freckles, and senile lentigines) 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
Each gram of Hydroquinone USP, 4% Time Release Cream contains 40 mg hydroquinone USP and retinyl palmitate (vitamin A) incorporated into microspheres composed of acrylates/C10-30 alkyl acrylate crosspolymer. This polymeric system provides gradual release of active ingredient into the skin. Other ingredients include ascorbic acid (vitamin C), ascorbyl palmitate, ascorbyl tetraisopalmitate, benzyl alcohol, bisabolol, butylated hydroxytoluene, cetyl alcohol, cyclopentasiloxane, edetate disodium, ethylhexyl palmitate, glycerin, glyceryl monostearate, light mineral oil, phenoxyethanol, poloxamer 188, polyoxyl 40 stearate, propyl gallate, purified water, Simmondsiachinensis(Jojoba) seed oil, sodium metabisulfite, sorbitan tristearate, tocopheryl acetate (vitamin E), tricontanyl PVP, and trolamine. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is:
Sources
Hydroquinone Time Release Manufacturers
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Perrigo New York Inc
Hydroquinone Time Release | Perrigo New York Inc
Hydroquinone USP, 4% Time Release Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. Promptly tighten cap after each use. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. 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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