Melpaque Hp Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
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.
There is currently no drug history available for this drug.
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: