Hydroquinone 8% / working resource
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Strengths above 4%
A compounded hydroquinone 8% cream, with what was studied at 4% and what was not in plain view. What should I know about strengths above 4%?
Open the Hydroquinone 8% library ↗A systematic review of published case studies of hydroquinone-associated ochronosis concluded that hydroquinone in concentrations above 4% and in treatment courses longer than 3 months may be associated with new-onset ochronosis.
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A systematic review of published case studies of hydroquinone-associated ochronosis concluded that hydroquinone in concentrations above 4% and in treatment courses longer than 3 months may be associated with new-onset ochronosis.
Supporting record ↗A DailyMed listing from one labeler names a hydroquinone 8% / tretinoin 0.025% emulsion in a 30gm package, shows the marketing status unapproved drug other, and states that the drug has not been found by FDA to be safe and effective and that the labeling has not been approved by FDA.
Supporting record ↗FDA states that currently Tri-Luma is the only FDA-approved drug containing hydroquinone, a prescription product approved for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face.
Supporting record ↗FDA states that compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.
Supporting record ↗A Cochrane review of melasma treatments concluded that the quality of studies evaluating melasma treatments was generally poor and available treatments inadequate, and called for high-quality randomised trials with long-term outcomes.
Supporting record ↗The Tri-Luma label (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) states that remission periods appeared to shorten between progressive courses of treatment and that few subjects (approximately 1 to 2%) maintained complete clearing of melasma.
Supporting record ↗The Tri-Luma label states that its safety and efficacy in patients of Fitzpatrick Skin Types V and VI have not been studied and that excessive bleaching in patients with darker skin cannot be excluded.
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