Nuquin Hp Recall
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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. Use of NUQUIN® HP 4% GEL 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 the hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in NUQUIN® HP 4% GEL provide the necessary sun protection during the process of skin bleaching. After clearing and during the maintenance period of therapy, sun exposure should be avoided on the bleached skin by the application of a suncreen or a sunblock agent, or protective clothing to prevent the skin from repigmenting.
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 a 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.
NUQUIN® HP 4% GEL 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 NUQUIN® HP 4% GEL (Hydroquinone 4%) Contains: ACTIVES: 40 mg of Hydroquinone USP, 50 mg of Padimate O USP and 30 mg of Dioxybenzone USP in a hydroalcoholic base of: INACTIVES: Alcohol, Carbomer, Disodium EDTA, Purified Water, Sodium Metabisulfite and Trolamine. Hydroquinone is 1, 4-Benzenediol. Hydroquinone is structurally related to monobenzone. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol and has a pKa of 9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2 and has a molecular weight of 110.11.
The structural formula is: