(HYDROQUINONE 3% SKIN BLEACHING TOPICAL SOLUTION)

Rx only

DESCRIPTION

Each mL of MELQUIN-3® TOPICAL SOLUTION contains ACTIVE: Hydroquinone 3.0% (30 mg) 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. The structural formula is:

C6H6O2

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 suppression 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)].

INDICATIONS AND USAGE

MELQUIN-3® TOPICAL SOLUTION is indicated for the temporary bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation.

CONTRAINDICATIONS

MELQUIN-3® TOPICAL SOLUTION is 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).

WARNINGS

1. 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.

2. 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 MELQUIN-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.

3. There are no sunblocking or sunscreening agents in MELQUIN-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 occuring. For daytime treatment use NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL or MELPAQUE HP 4% CREAM.

4. 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.

5. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to the lips.

PRECAUTIONS

(SEE WARNINGS)

ADVERSE REACTIONS

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.

OVERDOSAGE

There have been no systemic reactions reported from the use 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.

DOSAGE AND ADMINISTRATION

MELQUIN-3® TOPICAL SOLUTION should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by a physician. During the day, an effective broad spectrum sunscreen should be used and unnecessary solar exposure 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 MELQUIN-3® TOPICAL SOLUTION is normal and does not affect potency of the product.

HOW SUPPLIED

MELQUIN-3® TOPICAL SOLUTION (Hydroquinone 3%) is supplied in a 1 fl oz (29.57 mL) plastic bottle with applicator - NDC 58980-476-10

Distributed by:
STRATUS PHARMACEUTICALS INC
12379 SW 130TH STREET
MIAMI, FLORIDA 33186

Manufactured by:
Sonar Products, Inc.
Carlstadt, NJ 07072

Copyright ©1993, Stratus Pharmaceuticals, Inc.
All rights reserved.

HYDROQUINONE REFERENCES

1. Denton, C., A. Lerner and T. Fitzpatrick. "Inhibition of Melanin Formation by Chemical Agents." J. Invest. Derm. 18 (1952): 119-135. Print

2. Jimbow, K., M. Obata, M. Pathak and T. Fitzpatrick, "Mechanisms of Depigmentation by Hydroquinone" J. Invest. Derm. 62 (1974): 436-449. Print

3. Parrish, J, R Anderson , F Urbach, and D Pitts. "UV-A: Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet." Plenum Press, New York. (1978): 151. Print.

Rvsd. JG-MTSI 2012-339

PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box

Rx only

NDC 58980-476-10

MELQUIN-3®
TOPICAL SOLUTION
(HYDROQUINONE USP, 3%)

Keep container tightly closed.

Keep out of the reach
of children.

Distributed by:
STRATUS
PHARMACEUTICALS INC

Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186
Customer Service: 800-442-7882

NET CONTENTS: 1.0 FL OZ (29.57 ml)