FDA records indicate that there are no current recalls for this drug.
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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.
Hydroquinone USP, 4% Skin Bleaching Cream with Sunscreens is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.
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% Skin Bleaching Cream with Sunscreens is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
History
There is currently no drug history available for this drug.
Other Information
Each gram of Hydroquinone USP, 4% Skin Bleaching Cream with Sunscreens contains 40 mg Hydroquinone USP, 30 mg Dioxybenzone USP, 20 mg Oxybenzone USP and 80 mg Padimate O USP in a vanishing cream base of ascorbic acid, ceteareth-20, cetostearyl alcohol, diethylaminoethyl stearate, dimethicone, edetate disodium, glyceryl dilaurate, glyceryl monostearate, hydroxyethyl cellulose, lactic acid, myristalkonium chloride, octyldodecyl stearoyl stearate, polysorbate 80, propylene glycol, purified water, quaternium-14, quaternium-26, sodium metabisulfite, and stearyl alcohol. 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 With Sunscreens Manufacturers
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Preferred Pharmaceuticals, Inc
Hydroquinone With Sunscreens | Preferred Pharmaceuticals, Inc
Hydroquinone USP, 4% Skin Bleaching Cream with Sunscreens should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. 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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