{"active_ingredient":["Active Ingredient Minoxidil 2% w/v Purpose Hair regrowth treatment"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you have heart disease"],"do_not_use":["Do not use if your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you your have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth you do not know the reason for your hair loss you are under 18 year of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp"],"dosage_and_administration":["Directions prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist. apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area using more often will not improve results continued use is necessary or hair loss will begin again"],"effective_time":"20240822","id":"2046653c-a5e8-c010-e063-6294a90ae442","inactive_ingredient":["Inactive Ingredients Alcohol, Propylene Glycol, Purified Water"],"indications_and_usage":["Use to regrow hair on the scalp"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA078176"],"brand_name":["KERANIQUE Hair Regrowth Treatment For Women"],"generic_name":["MINOXIDIL"],"is_original_packager":[true],"manufacturer_name":["PROFECTUS BEAUTY, LLC"],"nui":["N0000175379","N0000175564"],"package_ndc":["70550-578-01","70550-578-02","70550-578-03","70550-578-04"],"pharm_class_epc":["Arteriolar Vasodilator [EPC]"],"pharm_class_pe":["Arteriolar Vasodilation [PE]"],"product_ndc":["70550-578"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1537947"],"spl_id":["2046653c-a5e8-c010-e063-6294a90ae442"],"spl_set_id":["8d580c01-a13d-81f8-e053-2a95a90a7426"],"substance_name":["MINOXIDIL"],"unii":["5965120SH1"]},"package_label_principal_display_panel":["Package Labelling:70550-578-01 Label1.jpg","Package Labelling:70550-578-02 Label2.jpg","Package Labelling:70550-578-03 Label3.jpg","Package Labelling:70550-578-04 Label4.jpg"],"pregnancy_or_breast_feeding":["May be harmful if used when pregnant or breastfeeding."],"purpose":["Purpose Hair regrowth treatment"],"questions":["Questions or Comments? Call toll free 1-888-237-4131 Visit website: www.keranique.com"],"set_id":"8d580c01-a13d-81f8-e053-2a95a90a7426","spl_product_data_elements":["KERANIQUE Hair Regrowth Treatment For Women MINOXIDIL ALCOHOL PROPYLENE GLYCOL WATER MINOXIDIL MINOXIDIL"],"spl_unclassified_section":["Drug Facts","Other Information see hair loss pictures on side of this carton before use, read all information on carton and enclosed booklet keep the carton. It contains important information. In clinical studies of mostly white women aged 18-45 years with mild to moderate diagnosis of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women imported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting incidental hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth). Store at Controlled Room Temperature 20 to 25 C (68° to 77° F)"],"stop_use":["Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months"],"version":"4","warnings":["Warnings. For external use only. Flammable: Keep away from fire or flame Do not use if your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you your have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth you do not know the reason for your hair loss you are under 18 year of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not apply on other parts of the body avoid eye contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for everyone. Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months May be harmful if used when pregnant or breastfeeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not apply on other parts of the body avoid eye contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for everyone."]}