Prescription Drugs

CLINICAL PHARMACOLOGY Topical application of hydroquinones produce a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) [Denton, C., et al, 1952 (1)] and supression of other melanocyte metabolic processes [Jimbow, K., et al, 1974 (2)]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J., et al, 1978 (3)].

Melquin-3 Topical Solution (hydroquinone) 3% Topical Solution DESCRIPTION Each mL of MELQUIN-3 TOPICAL SOLUTION Contains: ACTIVE: Hydroquinone 3% (30mg) INACTIVES: SD Alcohol 40B (45% by volume), Purified Water, Isopropyl Alcohol (4% by volume), Propylene Glycol, Laureth-4 Hydroxyethyl Cellulose and Ascorbic Acid. Hydroquinone is 1, 4-Benzenediol, with a chemical formula of C6H6O2 and a molecular weight of 110.11. Caution: FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL. OR OTIC USE.

INDICATIONS ALPHAQUIN HP 4% CREAMNUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION (hydroquinone 3% topical solution) are indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation. DOSAGE AND ADMINISTRATION NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. MELPAQUE HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by a physician. Do not rub MELPAQUE HP 4% CREAM in. During the day, an effective broad spectrum sunscreen should be used with MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION (hydroquinone 3% topical solution) . Unnecessary solar exposure should be avoided. There is no recommended dosage for children under 12 years of age except under the advice and supervision of a physician. Keep container tightly closed. NOTE: Slight darkening of NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION (hydroquinone 3% topical solution) is normal and does not affect potency of the product. HOW SUPPLIED MELQUIN-3 TOPICAL CREAM (Hydroquinone 3%) is supplied as follows: SIZE NDC NUMBER 1 FLUID OUNCE (29.57 ML.) 58980-0476-10 Stratus Pharmaceuticals Inc. FDA rev date: n/a

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE There have been no systemic reactions reported from the used of topical hydroquinone treatment. However, treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation which does not preclude treatment. CONTRAINDICATIONS ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION (hydroquinone 3% topical solution) are contraindicated in persons who have shown hypersensitivity to hydroquinone or any of the other ingredients. The safety of topical treatment of hydroquinone during pregnancy or in children (12 years and under) has not been established. (See PRECAUTIONS).

SIDE EFFECTS No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. DRUG INTERACTIONS No information provided.

WARNINGS Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication. To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation, or vesicle formation occurs. Use of ALPHAQUIN HP 4%, CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION (hydroquinone 3% topical solution) in paranasal and infraorbital areas increases the chance of irritations (See ADVERSE REACTIONS). If no improvement is seen after two months of treatment, use of this product should be discontinued. Sunscreen use is an essential aspect of hydroquinone therapy since even minimal sunlight exposure stimulates melanocyte activity. The sunscreens in ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM and NUQUIN HP 4% GEL and the sunblocks in MELPAQUE HP 4% CREAM provide the necessary sun protection during skin bleaching activity. During the depigmentation maintenance treatment subsequent to the intensive depigmentation therapy, sun exposure of the bleached skin should be avoided to prevent repigmentation. There are no sunblocking or sunscreen agents in MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION (hydroquinone 3% topical solution) . Sun exposure should be minimized by using a sunscreen agent, or protective clothing to cover bleached skin in order to prevent repigmentation from occurring. For daytime treatment use ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL or MELPAQUE HP 4% CREAM. NUQUIN HP 4% GEL contains Sodium Bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, MELPAQUE HP 4% CREAM and MELQUIN HP 4% CREAM contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and antiseptic effect may occur if applied to the lips. PRECAUTIONS (See WARNINGS) Pregnancy Category C Animal reproduction studies have not been conducted with hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered on a pregnant women or can affect reproductive capacity. It is also not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated. Nursing Mothers It is not known whether topical administration of hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by nursing mother. Pediatric Use Safety and effectiveness in children below the age of 12 years have not been established.