{"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":["Topical application of Hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxphenylalanine (dopa) and suppression of other melanocyte processes. The selective inhibition of the enzyme affects melanogenesis in the melanocytes resulting in cessation of melanin formation and subsequent reduction in pigmentation. Additional studies indicate Hydroquinone acts on the essential subcellular metabolic processes of melanocytes with resultant cytolysis, i.e. nonenzymediated depigmentation. Exposure to sunlight or ultraviolet light will cause repigmentalion of the bleached areas, which may be prevented by the use of sunblocking agents."],"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":["Sledgehammer contains Hydroquinone 40 mg/gm"],"dosage_and_administration":["Apply a thin layer on the skin surface in the affected areas twice a day or as directed by physician. Use of this product should be discontinued attar 4-6 months of treatment if no improvement is observed. The lightening effect may not be noticeable when used on very dark skin. Sun exposure should be avoided. PROTECT and SERVE SPF 30 or other broad-spectrum sunblock or protective clothing should be used to prevent reoccurring hyperpigmentation."],"effective_time":"20120305","id":"a4bf6d7d-59b8-489e-8170-1bc69252d27f","inactive_ingredient":["Arabldopsls Thallana Extract, Butylene Glycol, Caprylyl Glycol, Cyclopentasiloxane, CycIohexasiioxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Evodia Rutaecarpa Fruit Extract, Glycerin, Hexylene Glycol, Lecithin, Micrococcus Lysate, PEG/PPG-18/18 Dimethicone, Phenoxyathanol, Polysorbate 80, Purtned Water, Sodium Metabisulfite."],"indications_and_usage":["SLEDGEHAMMER is indicated for the gradual lightening of hyperpigmented skin conditions, such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Sunscreen must be used daily during Sledgehammer treatment."],"openfda":{},"overdosage":["There have been no systemic reactions from the use of topical Hydroquinone. However, treatment should be limited to relatMlly 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."],"package_label_principal_display_panel":["pictures U Carton"],"precautions":["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 be used in women only when clearty indicated. B . Nurning mothern. 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. C . Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established."],"set_id":"c296f8dd-bfa0-46aa-8ba3-c56325b2d780","spl_product_data_elements":["Sledgehammer Hydroquinone Hydroquinone Hydroquinone Cyclomethicone CYCLOMETHICONE 5 Dimethicone Polysorbate 80 Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Glycerin EDETATE DISODIUM Sodium Metabisulfite LECITHIN, SOYBEAN"],"storage_and_handling":["SLEDGEHAMMER should be stored at controlled room temperature (15-30 degrees C) (59-86 degrees F). Darkening of this product is normal. This will not affect performance or safety."],"version":"2","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 Hydroquinone Cream 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. Contact with the eyes should be aVoided. 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. Keep out of reach of children. If no bleaching or lightening effect is noted after 4-6 months of treatment use, Hydroquinone Cream should be discontinued. This product is formulated for use as a skinbleaching agent and should not be used for the prevention of sunburn. C . Sunscreen use is an essential aspect of the Hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent, or protective clothing to prevent repigmentation. There are no sunblocking or sunscreen agents in SLEDGEHAMMER and since minimal sunlight exposure may reverse the bleaching effect of this preparation, it should be used only at night or on areas of the body covered by protective clothing. During the daytime, sunblocking or broad-spectrum sunscreen preparations or protective clothing should be used to prevent the bleached areas from repigmentation. D . Keep this and all medications out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. E . Warning: SLEDGEHAMMER may cause serious allergic-type reactions in certain susceptible persons, such as hives, itching, wheezing, anaphylaxiz, and severe asthma attacks. Discontinue use immediately and contact your physician."]}