{"adverse_reactions":["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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunblocking agents or sunscreen agents contained in Obagi Nu-Derm Sunfader."],"contraindications":["CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established."],"description":["DESCRIPTION Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C 6 H 6 O 2 ; molecular weight is 110.0. Each gram of Obagi Nu-Derm Blender contains Hydroquinone USP 40 mg/gm in a base of purified water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, saponins, disodium EDTA, BHT, and propylparaben. Each gram of Obagi Nu-Derm Clear contains Hydroquinone USP 40 mg/gm in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, lactic acid, saponins, disodium EDTA, methylparaben, BHT, propylparaben, and butylparaben. Each gram of Obagi Nu-Derm Sunfader contains Hydroquinone USP 40 mg/gm, Octinoxate USP, 7.5%, and Oxybenzone USP, 5.5%, in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, saponins, propylparaben, BHT, and butylparaben. Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION A thin application should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation."],"effective_time":"20120517","general_precautions":["General Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment."],"how_supplied":["HOW SUPPLIED Obagi Nu-Derm Blender is available as follows: 2 oz. (57 gm) bottle NDC 62032-100-36 1 oz. (28.5 gm) bottle NDC 62032-100-10 Obagi Nu-Derm Clear is available as follows: 2 oz. (57 gm) bottle NDC 62032-101-36 1 oz. (28.5 gm) bottle NDC 62032-101-10 Obagi Nu-Derm Sunfader is available as: 2 oz. (57 gm) bottle NDC 62032-116-36 Store at 25°C (77°F); excursion permitted to 15°C-30°C (59°F-86°F)."],"how_supplied_table":["<table width=\"45%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr> <td>2 oz. (57 gm) bottle</td> <td>NDC 62032-100-36</td> </tr> <tr> <td>1 oz. (28.5 gm) bottle</td> <td>NDC 62032-100-10</td> </tr> </tbody> </table>","<table width=\"45%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr> <td>2 oz. (57 gm) bottle</td> <td>NDC 62032-101-36</td> </tr> <tr> <td>1 oz. (28.5 gm) bottle</td> <td>NDC 62032-101-10</td> </tr> </tbody> </table>","<table width=\"45%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr> <td>2 oz. (57 gm) bottle</td> <td>NDC 62032-116-36</td> </tr> </tbody> </table>"],"id":"ae234121-7d92-4fb6-9cfc-854beee1d0dd","indications_and_usage":["INDICATIONS AND USAGE The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Obagi Nu-Derm Sunfader is intended for daytime use as it contains sunscreen agents."],"nursing_mothers":["Nursing mothers It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Kit Carton OBAGI ® SYSTEM NU-DERM ® skin transformation system starter set normal/oily PRINCIPAL DISPLAY PANEL - Kit Carton"],"pediatric_use":["Pediatric usage Safety and effectiveness in children below the age of 12 years have not been established."],"precautions":["PRECAUTIONS (SEE WARNINGS ) General Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment. 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 a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated. Nursing mothers It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother. Pediatric usage Safety and effectiveness in children below the age of 12 years have not been established."],"pregnancy":["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 a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated."],"set_id":"c67b0629-5529-412d-99ee-186df4ecad5a","spl_product_data_elements":["NU-DERM STARTER SET NORMAL-OILY SKIN TRANSFORMATION SYSTEM Hydroquinone, Octinoxate, Oxybenzone and Zinc Oxide NU-DERM BLENDER Skin Lightener AND Blending HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM PPG-2 MYRISTYL ETHER PROPIONATE TROLAMINE SALICYLATE SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE PHENYL TRIMETHICONE NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE NU-DERM HEALTHY SKIN PROTECTION SPF 35 OCTINOXATE AND ZINC OXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE ISOPROPYL PALMITATE WATER ETHYLHEXYL STEARATE CETOSTEARYL ALCOHOL POLYSORBATE 60 C13-14 ISOPARAFFIN METHYLPARABEN LAURETH-7 PROPYLPARABEN EDETATE DISODIUM BUTYLPARABEN DIETHANOLAMINE CETYL PHOSPHATE PHENOXYETHANOL ETHYLPARABEN ISOBUTYLPARABEN SODIUM HYDROXIDE TRIETHOXYCAPRYLYLSILANE CITRIC ACID MONOHYDRATE NU-DERM FOAMING inert WATER GLYCERIN PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH SULFATE ALOE VERA LEAF SODIUM CHLORIDE ALFALFA WHOLE CHAMOMILE XANTHAN GUM D&C RED NO. 33 FD&C YELLOW NO. 5 NU-DERM TONER inert WATER GLYCERIN SODIUM PYRROLIDONE CARBOXYLATE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE POTASSIUM ALUM PANTHENOL SAGE CALENDULA OFFICINALIS FLOWER POLYSORBATE 80 ALLANTOIN ALOE VERA LEAF FD&C BLUE NO. 1 HAMAMELIS VIRGINIANA TOP WATER NU-DERM EXFODERM FORTE inert WATER GLYCERIN METHYLPARABEN PROPYLPARABEN POLYSORBATE 60 CETOSTEARYL ALCOHOL GLYCOLIC ACID TROLAMINE MEDIUM-CHAIN TRIGLYCERIDES LACTIC ACID CETYL ALCOHOL EMU OIL STEARIC ACID STEARYL ALCOHOL DIMETHICONE NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE Hydroquinone, Octinoxate, and Oxybenzone HYDROQUINONE HYDROQUINONE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE EDETATE DISODIUM SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE"],"spl_unclassified_section":["Rx Only FOR EXTERNAL USE ONLY","OMP, Inc. Long Beach, CA 90802 USA 1-800-636-7546 Rev. 8/03"],"storage_and_handling":["Store at 25°C (77°F); excursion permitted to 15°C-30°C (59°F-86°F)."],"version":"1","warnings":["WARNINGS Caution Hydroquinone is a skin bleaching agent which 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 by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Obagi Sunfader is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn. Warning Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons."]}