{"adverse_reactions":["VII. ADVERSE REACTIONS No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Sensitivity to sodium metabisulfate is a potential. See WARNINGS ."],"clinical_pharmacology":["II. 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 which may be prevented by the broad spectrum sunscreen agents contained in SunVanish."],"contraindications":["IV. 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":["I. DESCRIPTION Each 1 gram dose of SunVanish contains 40 mg of Hydroquinone USP, 75 mg of Octinoxate, 50 mg of Oxybenzone, 20 mg of Avobenzone, and 18.6 mg of Octocrylene in a cream base of Purified Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Sodium Lauryl Sulfate, Isopropyl Palmitate, Sodium Metabisulfite, Sorbic Acid, and Disodium EDTA."],"dosage_and_administration":["IX. DRUG DOSAGE AND ADMINISTRATION SunVanish should be applied in the morning to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential."],"effective_time":"20190205","how_supplied":["X. HOW SUPPLIED SunVanish is available as follows: Size NDC Number Net Wt. 2 Oz. / 56 g tube 64760-401-02 SunVanish should be stored at controlled room temperature 15° - 30° C (59° - 86° F). Do not expose to heat above 86° F or direct sunlight. Distributed by: Genesis Pharmaceutical, Inc. Parsippany, NJ 07054 Made in U.S.A. 1-800-GLYTONE (459-8663) www.glytone-usa.com Rev. 062413 PF logo"],"id":"812c7e75-4c32-07f3-e053-2991aa0a43b1","indications_and_usage":["III. INDICATIONS AND USAGE SunVanish is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation."],"nursing_mothers":["B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers."],"openfda":{},"overdosage":["VIII. OVERDOSAGE There have been no systemic reactions from the use of topical hydroquinone in SunVanish in recommended quantities. However, 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, but indicates caution is warranted."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY - Sunvanish Carton 56 g NDC 64760-401-02 GLYTONE CLARIFYING Rx ONLY skin beaching sunvanish with Broad Spectrum Sunscreen SPF 25 HYDROQUINONE, USP 4% NET WT. 56 g / 2 OZ. SunVanish Carton 56 g"],"pediatric_use":["C. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age."],"precautions":["VI. 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 a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should not be used in pregnant women. B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers. C. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age."],"pregnancy":["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 a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should not be used in pregnant women."],"set_id":"dc333304-b8e8-449e-87f5-2d692cbaa1dc","spl_product_data_elements":["Glytone Clarifying SunVanish with Sunscreen Hydroquinone WATER PROPYLENE GLYCOL CETOSTEARYL ALCOHOL GLYCERIN SODIUM LAURYL SULFATE ISOPROPYL PALMITATE SODIUM METABISULFITE SORBIC ACID EDETATE DISODIUM HYDROQUINONE HYDROQUINONE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE"],"spl_unclassified_section":["Skin Bleaching SunVanish with sunscreen HYDROQUINONE USP, 4% RX only FOR EXTERNAL USE ONLY"],"version":"5","warnings":["V. WARNINGS A. 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. B. Test for skin sensitivity before using SunVanish 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 warm water and contact their physician. If no bleaching or lightening effect is noted after 2 months of treatment, SunVanish should be discontinued. SunVanish is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn. C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in SunVanish provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a broad spectrum sunscreen greater than SPF 15 and protective clothing to prevent repigmentation. D. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. E. WARNING: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. 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."]}