Aclaro Emulsion

Name: Aclaro Emulsion

Description



Rx only
For topical use only
Not for ophthalmic use

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, h ydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6 H6 O2; molecular weight 110.1.The structural formula is:









Active Ingredients: hydroquinone USP 4% Other Ingredients: ascorbic acid, benzyl alcohol, butyl methoxydibenzoylmethane, C12-15 alkyl benzoate, cetearyl octanoate, cetyl alcohol, cetyl esters, cetyl palmitate, DEA cetyl phosphate, dimethicone, disodium EDTA, ethylhexyl methoxycinnamate, glycerin, glycolic acid, ammonium glycolate, hydroxyethylcellulose, phenoxyethanol, purified water, sodium metabisulfite, and 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) and suppression of other melanocyte metabolic processes. 2

Contraindications


Aclaro® 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® (hydroquinone USP 4%) 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® 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® emulsion provide the necessary sun protection during therapy. During and after the use of Aclaro® 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. Contains sodium metabisulfite, a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.

F. 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.

Precautions


See Warnings: 

Overdosage Section


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


(web3)