Aclaro PD Emulsion

Name: Aclaro PD Emulsion

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.

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 ingredients. The safety of topical hydroquinone use during pregnancy or on
children (12 years and under) has not been established.

Warnings

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 Aclaro PD® (hydroquinone USP 4%) bioadhesive emulsion 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 Aclaro PD® bioadhesive emulsion should be discontinued.

C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocyte activity. The sunscreens in Aclaro PD® bioadhesive emulsion provide the necessary sun protection during therapy. During and after the use of Aclaro PD® bioadhesive emulsion, 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 poison control center immediately.

E. On rare occasions, a gradual blue-black darkening of the skin may occur. If this occurs, the product should be discontinued and a physician contacted immediately.

Overdosage

There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Dosage and Administration

Aclaro PD® bioadhesive emulsion should be applied to the affected areas twice daily, or as directed by a physician. 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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