{"active_ingredient":["Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo"],"active_ingredient_table":["
Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo
"],"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":["
adults and children 12 years and overwet hair thoroughlyapply 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 yearsask a doctor
"],"effective_time":"20250711","id":"adf1b4c5-24ad-4b4e-8ad6-f28d77d244ea","inactive_ingredient":["Inactive ingredients benzyl alcohol, BHT, citric acid, cocamide MEA, FD&C Blue 1, FD&C Yellow 5, fragrance, glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, sodium laureth sulfate, tetrasodium EDTA, water"],"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":["55505-232-65"],"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":["55505-232"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["240812","608844"],"spl_id":["adf1b4c5-24ad-4b4e-8ad6-f28d77d244ea"],"spl_set_id":["8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6"],"substance_name":["KETOCONAZOLE"],"unii":["R9400W927I"],"upc":["0053076000221"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Center panel NEW SCENT! Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO PEPPERMINT COMPLEX + TEA TREE ESSENCE Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff REFRESHING peppermint complex + tea tree essence 14 fl oz (400 mL) right panel 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. left panel Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 KRAMER LABORATORIES Made in Canada Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2025 KRAMER LABORATORIES, INC. P221B16000 Lot: Exp: YYYY-MM Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO PEPPERMINT COMPLEX + TEA TREE ESSENCE CLINICALLY PROVEN to control flaking scaling and itching from dandruff CONTROLS fungus that can cause dandruff REFRESHING peppermint complex + tea tree essence 14 fl oz (400 mL) P221H13000 P221H14000 LOT EXP YYYY-MM"],"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":["
Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo
"],"questions":["Questions or comments? call 1-800-824-4894 Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA ©2025 Kramer Laboratories, Inc. Made in Canada"],"set_id":"8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6","spl_product_data_elements":["Nizoral Ketoconazole Ketoconazole Ketoconazole Benzyl Alcohol Butylated Hydroxytoluene Citric Acid Monohydrate Coco Monoethanolamide Fd&C Blue No. 1 Fd&C Yellow No. 5 Glycol Distearate Hydrochloric Acid Hypromellose, Unspecified Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) Sodium Benzoate Sodium Chloride Sodium Cocoyl Sarcosinate Sodium Hydroxide Sodium Laureth-3 Sulfate Edetate Sodium Water 400 mL Carton front label back label"],"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":"1","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"]}