Spotless Cream

Hydroquinone

Indications

Spotless is indicated –

• For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
• To reduce hyperpigmentation caused by photosensitization associated with inflammation or with the use of certain cosmetics.

Pharmacology

Hydroquinone is a topical depigmentating agent that produces a reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine and suppressing melanocyte metabolic processes.

Dosage & Administration

Apply a thin film of Hydroquinone Cream to the effected area once daily, at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply Hydroquinone Cream to the hyperpigmented areas of melasma including about ½ inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin.

Therapy should be discontinued when control is achieved. During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. Hydroquinone Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Contraindications

Hydroquinone is contraindicated to patients with prior history of hypersensitivity or allergic reaction to hydroquinone or other ingredients in the preparation.

Side Effects

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued.

Pregnancy & Lactation

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Lactation: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

Precautions & Warnings

Spotless is a skin bleaching 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.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin to check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. If no bleaching or lightening effect is noted after 2 months of treatment, the medication should be discontinued.

Contact with the eyes and lips should be avoided. Spotless should not be applied to cut or abraded skin.

Overdose Effects

There have been no systemic reactions from the use of topical Spotless. Some patients may experience a transient reddening of skin and mild burning sensation which does not preclude treatment.

Therapeutic Class

Hydroquinone Preparations

Storage Conditions

Store between 20-25° C. Protect from light.