PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 30 Tube Box. NDC 30815-0040-1Rx OnlyHYDRO-Q 4% GEL(R) (Hydroquinone 4%) Gel(R)SKIN BLEACHING GELDermAvance(R) Advanced Skin Carewww.DermAvance.com30 g. PRINCIPAL DISPLAY PANEL 30 Tube Box.

PEDIATRIC USE SECTION.

C. Pediatric usage. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. 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.

CLINICAL PHARMACOLOGY SECTION.

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

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. HYDRO-Q(R) is contraindicated in any patient that has 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.

DESCRIPTION SECTION.

HYDRO-Q(R) 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 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINSTRATION. HYDRO-Q(R) should be applied to the affected areas twice daily, morning and before bedtime or as directed by physician.During and after the use of HYDRO-Q(R), sun exposure should be limited and 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(R) 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 physician.

HOW SUPPLIED SECTION.

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

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. HYDRO-Q(R) is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and areas of melanin hyperpigmentation.

NURSING MOTHERS SECTION.

B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when used by nursing mother.

OVERDOSAGE SECTION.

OVERDOSAGE. There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience skin reddening and mild burning sensation that does not preclude treatment.

PRECAUTIONS SECTION.

PRECAUTIONS. See Warnings A. Pregnancy Category C. 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 pregnant woman, or can affect reproductive capacity.. B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when used by nursing mother.. C. Pediatric usage. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

PREGNANCY SECTION.

A. Pregnancy Category C. 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 pregnant woman, or can affect reproductive capacity.

REFERENCES SECTION.

REFERENCES. Denton C, Fitzpatrick TB, Lerner AB. Inhibition of melanin formation by chemical agents. Invest Dermatology. 1952; 18: 119-135.Fitzpatrick TB, Jimbow K, Obata M, Panthak M. Mechanism of depigmentation by hydroquinone. Invest Dermatology. 1974; 62: 436-449.Anderson RR, Parrish JA, Pitts D, Urbach F. UVA, Biological Effects of Ultraviolet Radiation With Emphasis on Human Responses to Longwave Ultraviolet. New York and London: Plenum Press; 1978: 151.. Denton C, Fitzpatrick TB, Lerner AB. Inhibition of melanin formation by chemical agents. Invest Dermatology. 1952; 18: 119-135.. Fitzpatrick TB, Jimbow K, Obata M, Panthak M. Mechanism of depigmentation by hydroquinone. Invest Dermatology. 1974; 62: 436-449.. Anderson RR, Parrish JA, Pitts D, Urbach F. UVA, Biological Effects of Ultraviolet Radiation With Emphasis on Human Responses to Longwave Ultraviolet. New York and London: Plenum Press; 1978: 151.

SPL UNCLASSIFIED SECTION.

RX OnlyFOR EXTERNAL USE ONLY.

STORAGE AND HANDLING SECTION.

Store at controlled room temperature, between 15 and 30C (59and 86F).

WARNINGS SECTION.

WARNINGS. CAUTION: Hydroquinone is depigmenting agent that may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.Test for skin sensitivity before using HYDRO-Q(R) by applying small amount of the gel to an unbroken patch of skin and check within 24 hours. Minor redness is not contraindication but where there is itching and vesicle formation or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. If no lightening effect is noted after months of treatment the use of HYDRO-Q(R) should be discontinued. HYDRO-Q(R) is formulated for the treatment of dyschromia and should not be used for the prevention of sunburn.Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of broad spectrum sunscreen SPF 15 or greater) or by use of protective clothingKeep this and all medications out of reach of children. In case of accidental ingestion, contact physician or poison control center immediately.WARNING: Contains sodium metabisulfite, sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible personsOn rare occasions, gradual blue-black darkening of the skin may occur, in which case, use of HYDRO-Q(R) should be discontinued and physician contacted immediately. CAUTION: Hydroquinone is depigmenting agent that may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.. Test for skin sensitivity before using HYDRO-Q(R) by applying small amount of the gel to an unbroken patch of skin and check within 24 hours. Minor redness is not contraindication but where there is itching and vesicle formation or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. If no lightening effect is noted after months of treatment the use of HYDRO-Q(R) should be discontinued. HYDRO-Q(R) is formulated for the treatment of dyschromia and should not be used for the prevention of sunburn.. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of broad spectrum sunscreen SPF 15 or greater) or by use of protective clothing. Keep this and all medications out of reach of children. In case of accidental ingestion, contact physician or poison control center immediately.. WARNING: Contains sodium metabisulfite, sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. On rare occasions, gradual blue-black darkening of the skin may occur, in which case, use of HYDRO-Q(R) should be discontinued and physician contacted immediately.