DailyMed Label: Hydro-Q

DailyMed Label: Hydro-Q

2023

DailyMed Prescription

Hydro-Q

Hydroquinone

Dermavance Pharmaceuticals

NDC: 30815-0040

NDC: 30815-0040

NDC: 30815-0040

HYDRO-Q ® contains hydroquinone USP 4%. Hydroquinone is 1, 4-Benzenediol {CAS 123-31-91}. 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; The molecular weight is 110.1. The structural formula is: Chemical Structure

HYDRO-Q ® is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and areas of melanin hyperpigmentation.

HYDRO-Q ® should be applied to the affected areas twice daily, morning and before bedtime or as directed by a physician. During and after the use of HYDRO-Q ® , sun exposure should be limited and a sunscreen agent or protective clothing should be used to cover up the treated areas to prevent regimentation. If no lightening effect is noted after two months of treatment, use of HYDRO-Q ® should be discontinued. There is no recommended dosage for children under the age of 12 years of age except under the advice and supervision of a physician.

HYDRO-Q ® is contraindicated in any patient that has a prior history of sensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

See Warnings Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman, or can affect reproductive capacity. It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when used by a nursing mother. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately

HYDRO-Q ® (Hydroquinone 4%) Gel is supplied in a 30 g tube. NDC: 30815-0040-1 Store at controlled room temperature, between 15° and 30°C (59°and 86°F).

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) 1 and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause regimentation of the bleached areas.

NDC 30815-0040-1 Rx Only HYDRO-Q 4% GEL ® (Hydroquinone 4%) Gel® SKIN BLEACHING GEL DermAvance ® Advanced Skin Care www.DermAvance.com 30 g PRINCIPAL DISPLAY PANEL - 30 g Tube Box