Aclaro Hydroquinone
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Questions & Answers
Side Effects & Adverse Reactions
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.
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
Aclaro® is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration resulting rom the use of oral contraceptives, pregnancy, hormone replacment therapy, or skin trauma.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Aclaro Hydroquinone Manufacturers
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Innocutis
![Aclaro Hydroquinone (Hydroquinone ) Emulsion [Innocutis]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Aclaro Hydroquinone | Innocutis
Apply Umecta topical suspension to affected skin twice per day or as directed by a physician. Rub in until completely absorbed.
Aclaro® 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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