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Aclaro PD Emulsion
  • Professionals
  • FDA PI

Aclaro PD Emulsion

Generic name:hydroquinone
Dosage form: topical emulsion
Drug class:Topical depigmenting agents

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Description

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 with 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:




ACTIVE INGREDIENT: hydroquinone USP 4%. Other Ingredients: ascorbic acid, benzyl alcohol, butyl methoxydibensoyl methane, C12-15 alkyl benzoate, cetearyl ethylhexanoate, cetyl alcohol, cetyl esters, cetyl palmitate, DEA – cetyl phosphate, dimethicone, dimethylacrylamide/acrylic acid/polystyrene ethyl methacrylate copolymer, disodium EDTA, ethylhexyl methoxycinnamate, glycerine, glycolic acid, hydroxyl ethyl cellulose, phenoxyethanol, propylene glycol (and) BHA (and) citric acid, purified water, sodium hydroxide solution,stearic acid.

Clinical Pharmacology

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)1 and suppression of other melanocyte metabolic processes.2

Indications and Usage

Aclaro PD® is 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.

Contraindications

Aclaro PD® is contraindicated in any patient that has a prior history of hypersensitivity or allergic reaction to hydroquinone or any of the other