{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "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" ], "active_ingredient": [ "Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo" ], "active_ingredient_table": [ "
Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo
" ], "purpose": [ "Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo" ], "purpose_table": [ "
Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo
" ], "indications_and_usage": [ "Uses controls flaking, scaling and itching associated with dandruff" ], "warnings": [ "Warnings For external use only" ], "do_not_use": [ "Do not use on scalp that is broken or inflamed if you are allergic to ingredients in this product" ], "when_using": [ "When using this product avoid contact with eyes if product gets into eyes, rinse thoroughly with water" ], "ask_doctor": [ "Stop use and ask a doctor if rash appears condition worsens or does not improve in 2-4 weeks" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a doctor before use." ], "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." ], "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": [ "
adults and children 12 years and overwet hair thoroughlyapply shampoo, generously lather, rinse thoroughly. Repeatuse 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 yearsask a doctor
" ], "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" ], "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" ], "questions": [ "Questions or comments? call 1-800-824-4894" ], "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" ], "set_id": "f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88", "id": "d92aa7b7-48b6-4db5-9db4-85f4f4dd563d", "effective_time": "20250821", "version": "2", "openfda": { "application_number": [ "NDA020310" ], "brand_name": [ "Nizoral" ], "generic_name": [ "KETOCONAZOLE" ], "manufacturer_name": [ "Kramer Laboratories" ], "product_ndc": [ "55505-233" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "KETOCONAZOLE" ], "rxcui": [ "240812", "608844" ], "spl_id": [ "d92aa7b7-48b6-4db5-9db4-85f4f4dd563d" ], "spl_set_id": [ "f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88" ], "package_ndc": [ "55505-233-65" ], "is_original_packager": [ true ], "nui": [ "N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "pharm_class_moa": [ "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "R9400W927I" ] } } ] }