{"active_ingredient":["Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo"],"active_ingredient_table":["<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td styleCode=\"Lrule Toprule\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredient</content></content></td><td align=\"right\" styleCode=\"Rrule Toprule\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></td></tr><tr><td styleCode=\"Botrule Lrule\">Ketoconazole 1% w/w</td><td align=\"right\" styleCode=\"Botrule Rrule\">Anti-dandruff shampoo</td></tr></tbody></table>"],"ask_doctor":["Stop use and ask a doctor if rash appears condition worsens or does not improve in 2-4 weeks"],"do_not_use":["Do not use on scalp that is broken or inflamed if you are allergic to ingredients in this product"],"dosage_and_administration":["Directions adults and children 12 years and over wet hair thoroughly apply shampoo, generously lather, rinse thoroughly. Repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff children under 12 years ask a doctor"],"dosage_and_administration_table":["<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"45%\"><colgroup><col width=\"30%\"/><col width=\"70%\"/></colgroup><tbody><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">adults and children  12 years and over</td><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"Square\"><item>wet hair thoroughly</item><item>apply shampoo, generously lather,  rinse thoroughly. Repeat</item><item>use every 3-4 days for up to 8 weeks  or as directed by a doctor. Then use  only as needed to control dandruff</item></list></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">children under  12 years</td><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"Square\"><item>ask a doctor</item></list></td></tr></tbody></table>"],"effective_time":"20250821","id":"d92aa7b7-48b6-4db5-9db4-85f4f4dd563d","inactive_ingredient":["Inactive ingredients water, sodium laureth sulfate, sodium cocoyl sarcosinate, cocamide MEA, glycol distearate, benzyl alcohol, hydroxypropyl methylcellulose, polyquaternium-7, tetrasodium EDTA, fragrance, sodium chloride, BHT, citric acid, sodium benzoate, hydrochloric acid, sodium hydroxide, blue 1"],"indications_and_usage":["Uses controls flaking, scaling and itching associated with dandruff"],"keep_out_of_reach_of_children":["Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["NDA020310"],"brand_name":["Nizoral"],"generic_name":["KETOCONAZOLE"],"is_original_packager":[true],"manufacturer_name":["Kramer Laboratories"],"nui":["N0000175487","M0002083","N0000182141","N0000190115","N0000185503"],"package_ndc":["55505-233-65"],"pharm_class_cs":["Azoles [CS]"],"pharm_class_epc":["Azole Antifungal [EPC]"],"pharm_class_moa":["Cytochrome P450 3A4 Inhibitors [MoA]","Cytochrome P450 3A5 Inhibitors [MoA]","P-Glycoprotein Inhibitors [MoA]"],"product_ndc":["55505-233"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["240812","608844"],"spl_id":["d92aa7b7-48b6-4db5-9db4-85f4f4dd563d"],"spl_set_id":["f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88"],"substance_name":["KETOCONAZOLE"],"unii":["R9400W927I"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Shampoo + conditioner Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO 2-IN-1 Anti Drandruff Shampoo + Conditioner CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CONDITIONS leaves hair soft, smooth & manageable 14 fl oz (400mL) What Causes Dandruff? Dandruff can have many causes. A fungus found on every human head is often associated with dandruff. How Does Nizoral ® Anti-Dandruff Work? NIZORAL ® Anti-Dandruff is the only over-the-counter anti-dandruff shampoo that has Ketoconazole, an effective antifungal. Ketoconazole works by controlling fungus often associated with dandruff, and once the fungus is controlled, so are your dandruff symptoms. Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Nizoral ® 2-IN-1 Anti-Dandruff Shampoo + Conditioner is formulated with more conditioning properties to help leave hair soft, smooth, and manageable. KRAMER LABORATORIES Made in Canada Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2025 KRAMER LABORATORIES, INC. Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 P238B15000 Lot: Exp: YYYY-MM K0524"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a doctor before use."],"purpose":["Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo"],"purpose_table":["<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td styleCode=\"Lrule Toprule\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredient</content></content></td><td align=\"right\" styleCode=\"Rrule Toprule\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></td></tr><tr><td styleCode=\"Botrule Lrule\">Ketoconazole 1% w/w</td><td align=\"right\" styleCode=\"Botrule Rrule\">Anti-dandruff shampoo</td></tr></tbody></table>"],"questions":["Questions or comments? call 1-800-824-4894"],"set_id":"f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88","spl_product_data_elements":["Nizoral Ketoconazole Ketoconazole Ketoconazole Benzyl Alcohol Butylated Hydroxytoluene Fd&C Blue No. 1 Citric Acid Monohydrate Coco Monoethanolamide Glycol Distearate Hydrochloric Acid Hypromellose, Unspecified Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) Sodium Chloride Sodium Cocoyl Sarcosinate Sodium Hydroxide Sodium Laureth-3 Sulfate Edetate Sodium Water Sodium Benzoate 400mL Carton"],"storage_and_handling":["Other information store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date"],"version":"2","warnings":["Warnings For external use only"],"when_using":["When using this product avoid contact with eyes if product gets into eyes, rinse thoroughly with water"]}