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Melpaque HP Cream

Generic Name: hydroquinone
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

MELPAQUE® HP
4% CREAM Rx

(HYDROQUINONE 4% USP
SKIN BLEACHING MOISTURIZING
TOPICAL CREAM WITH SUNBLOCK)

Rx only

FOR EXTERNAL USE ONLY: NOT
FOR OPHTHALMIC, NASAL OR
OTIC USE.

Melpaque HP Cream Description

Each gram of MELPAQUE® HP 4% CREAM contains ACTIVE: 40mg of Hydroquinone USP in a tinted sunblocking cream base of INACTIVES: Edetate Disodium, Glyceryl Monostearate SE, Iron Oxides, Methyl Paraben, Mineral Oil, Polyoxyl (40) Stearate, Polyoxyethylene (25) Propylene Glycol Stearate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Metabisulfite, Squalene, Stearic Acid and Talc.

Hydroquinone is 1, 4-Benzenediol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

The structural formula is:

C6H6O2

Melpaque HP Cream - Clinical Pharmacology

Topical application of hydroquinone produces 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.A. et al., 1978 (3)].

Indications and Usage for Melpaque HP Cream

MELPAQUE® HP 4% CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation.

Contraindications

MELPAQUE® HP 4% CREAM 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. Close patient supervision is recommended. Use of MELPAQUE® HP 4% CREAM 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. Sunscreen use is an essential aspect of hydroquinone therapy since even minimal sunlight exposure stimulates melanocyte activity. 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.

4. 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.

5. 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.

6. 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 woman 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 a nursing mother.

Pediatric Use

Safety and effectiveness in children below the age of 12 years has not been established.

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.

Melpaque HP Cream Dosage and Administration

MELPAQUE® HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by a physician. 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 MELPAQUE® HP 4% CREAM is normal and does not affect potency of the product.

How is Melpaque HP Cream Supplied

MELPAQUE® HP 4% CREAM (Hydroquinone, USP 4%) is supplied as follows:

SIZE NDC NUMBER
1 oz tube (28.35 grams) 58980-473-10

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.

Keep out of the reach of children.

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

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

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

Rev. JG-MPCI 2014-311

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

NDC 58980-473-10
Net WT. 1 oz (28.35g)

WITH SUNBLOCKS

MELPAQUE® HP 4% CREAM
(HYDROQUINONE USP, 4%)

STRATUS
PHARMACEUTICALS INC

SKIN BLEACHING CREAM WITH SUNBLOCKS

Distributed by Stratus Pharmaceuticals Inc, 12379 SW 130th Street, Miami, Florida 33186

Rx only

MELPAQUE HP 
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-473
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
GLYCERIN  
Stearic Acid  
GLYCERYL MONOSTEARATE  
SQUALENE  
Mineral Oil  
METHYLPARABEN  
PROPYLPARABEN  
SODIUM METABISULFITE  
PROPYLENE GLYCOL  
EDETATE SODIUM  
POTASSIUM SORBATE  
Talc  
FERRIC OXIDE RED  
POLYOXYL 40 STEARATE  
PEG-25 PROPYLENE GLYCOL STEARATE  
Product Characteristics
Color ORANGE (Rust Colored) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:58980-473-10 1 TUBE in 1 BOX
1 28.35 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/02/2001
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc. 104283945 MANUFACTURE(58980-473)
Revised: 11/2014
 
Stratus Pharmaceuticals
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