{"id":"hydroquinone","rwe":[],"_fda":{"id":"3ab1e224-767b-2492-e063-6294a90a5a06","set_id":"10b923cc-1486-cd97-e063-6294a90a95d1","openfda":{"nui":["N0000175851","N0000175854","N0000175850"],"unii":["XV74C1N1AE"],"route":["TOPICAL"],"spl_id":["3ab1e224-767b-2492-e063-6294a90a5a06"],"brand_name":["Vivant True Tone Forte"],"spl_set_id":["10b923cc-1486-cd97-e063-6294a90a95d1"],"package_ndc":["63750-001-01"],"product_ndc":["63750-001"],"generic_name":["HYDROQUINONE"],"product_type":["HUMAN OTC DRUG"],"pharm_class_pe":["Depigmenting Activity [PE]"],"substance_name":["HYDROQUINONE"],"pharm_class_epc":["Melanin Synthesis Inhibitor [EPC]"],"pharm_class_moa":["Melanin Synthesis Inhibitors [MoA]"],"manufacturer_name":["Vivant Pharmaceuticals, LLC"],"is_original_packager":[true]},"purpose":["Indication Skin Lightening"],"version":"3","stop_use":["Stop use and ask the doctor if excessive skin irritation develops or increases"],"warnings":["Warnings Warnings ■Sun exposure should be avoided indefinitely by using a high SPF sunscreen agent, a sunblocking agent, or protective clothing to cover bleached skin in order to prevent darkening from reoccurring ■ Do not get into eyes ■Keep out of reach of children ■For external use only ■Not recommended for children under 12 years of age ■ If swallowed get medical help or contact a poison control center immediately."],"ask_doctor":["Ask a doctor if you are: using other topical acne medications"],"when_using":["When using this product if not improvement is seen after 2 months of treatment, use of this products should be discontinued"],"effective_time":"20250724","active_ingredient":["Active Ingredient Hydroquinone (2%)"],"inactive_ingredient":["Inactive Ingredients Alcohol Denat, Ethoxydiglycol, Ethylhexyl Dimethyl PABA Hydroquinone USP, Kojic Acid USP, Citric Acid USP, Retinyl Propionate Propylene Glycol, Hydroxypropylcellulose"],"indications_and_usage":["Uses Uses ■ For the gradual fading of age spots ■ Lightens dark pigment in the skin ■This product provides minimal SPF protection."],"dosage_and_administration":["Directions Directions ■ Adult topical dosage is a thin layer to the affected area once or twicedaily■There is no recommended dosage for children under 12 years of age except under the advice and supervision of a doctor ■ Keep refrigerated"],"spl_product_data_elements":["Vivant True Tone Forte Hydroquinone ALCOHOL DIETHYLENE GLYCOL MONOETHYL ETHER PADIMATE O KOJIC ACID ANHYDROUS CITRIC ACID RETINYL PROPIONATE PROPYLENE GLYCOL LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 140000 MW) HYDROQUINONE HYDROQUINONE"],"keep_out_of_reach_of_children":["Warnings Keep out of reach of children■For external only■Not recommended for children under12 years of age"],"package_label_principal_display_panel":["Principal Display Panel label"]},"tags":[{"label":"Melanin Synthesis Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Carbonic anhydrase 2","category":"target"},{"label":"CA2","category":"gene"},{"label":"CA12","category":"gene"},{"label":"CA3","category":"gene"},{"label":"D11AX11","category":"atc"},{"label":"Cutaneous","category":"route"},{"label":"Topical","category":"route"},{"label":"Cloth","category":"form"},{"label":"Cream","category":"form"},{"label":"Active","category":"status"},{"label":"Chloasma","category":"indication"},{"label":"Discoloration of skin","category":"indication"},{"label":"Facial Hyperpigmentation","category":"indication"},{"label":"Galderma Labs Lp","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Antioxidants","category":"pharmacology"},{"label":"Mutagens","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Radiation-Protective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"ERYTHEMA","source":"FDA FAERS","actionTaken":"174 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"159 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"104 reports"},{"date":"","signal":"SKIN BURNING SENSATION","source":"FDA FAERS","actionTaken":"98 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"85 reports"},{"date":"","signal":"SKIN EXFOLIATION","source":"FDA FAERS","actionTaken":"81 reports"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"73 reports"},{"date":"","signal":"DRY SKIN","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"62 reports"},{"date":"","signal":"PRODUCT USE ISSUE","source":"FDA FAERS","actionTaken":"58 reports"}],"commonSideEffects":[{"effect":"Dryness","drugRate":"","severity":"common","organSystem":""},{"effect":"Fissuring of paranasal and infraorbital areas","drugRate":"","severity":"common","organSystem":""},{"effect":"Erythema","drugRate":"","severity":"common","organSystem":""},{"effect":"Stinging","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Adrenal cortical hypofunction","Atrophoderma","Breastfeeding (mother)","Denuded skin","Eczema","Peripheral vascular disease","Pregnancy, function","Sunburn","Telangiectasia disorder"],"specialPopulations":{"Pregnancy":"Topical hydroquinone should be given to pregnant woman only if clearly needed. Animal reproduction studies have not been conducted with topical hydroquinone. 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