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Nizoral - Prescription Drug Labeling

Product NDC Code 55505-192
Drug Name

Nizoral

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS],
Cytochrome P450 3A4 Inhibitors [MoA],
Cytochrome P450 3A5 Inhibitors [MoA],
P-Glycoprotein Inhibitors [MoA]
Active Ingredients
Ketoconazole 10 mg/ml
Route TOPICAL
Dosage Form SHAMPOO
RxCUI drug identifier 240812,
608844
Application Number NDA020310
Labeler Name Kramer Laboratories
Packages
Package NDC Code Description
55505-192-33 1 bottle in 1 carton (55505-192-33) > 125 ml in 1 bottle
55505-192-40 1 bottle in 1 carton (55505-192-40) > 200 ml in 1 bottle
55505-192-57 2 carton in 1 carton (55505-192-57) > 1 bottle in 1 carton > 200 ml in 1 bottle
55505-192-59 2 carton in 1 carton (55505-192-59) > 325 ml in 1 carton

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Ketoconazole 1% Anti-dandruff shampoo
Active ingredientPurpose
Ketoconazole 1%Anti-dandruff shampoo

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzyl alcohol, BHT, blue 1, citric acid, cocamide MEA, fragrance, glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, sodium laureth sulfate, tetrasodium EDTA, water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses controls flaking, scaling and itching associated with dandruff

Purpose

Information about the drug product’s indications for use.
Active ingredient Purpose Ketoconazole 1% Anti-dandruff shampoo
Active ingredientPurpose
Ketoconazole 1%Anti-dandruff shampoo

Spl product data elements

Usually a list of ingredients in a drug product.
Nizoral Ketoconazole Ketoconazole Ketoconazole Benzyl Alcohol Butylated Hydroxytoluene Fd&C Blue No. 1 Citric Acid Monohydrate Coco Monoethanolamide Glycol Distearate Hydrochloric Acid Hypromelloses Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) Sodium Chloride Sodium Cocoyl Sarcosinate Sodium Hydroxide Sodium Laureth-3 Sulfate Edetate Sodium Water 125 mL back 200 mL back 200mL Carton 200 mL front 125mL Carton 125 mL front Nizoral Twin Pack 2 x.200ml Nizoral Value packs 2 x 200 mL + 125 mL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 7 fl oz (200mL) 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 ® 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. 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 Belgium Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2020 KRAMER LABORATORIES, INC. USA 729504 875 Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO 1% Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 7 fl oz (200mL) USA - 729505 Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA © 2019 Kramer Laboratories, Inc. Made in Belgium USA - 696880 LOT EXP Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 4 fl oz (125mL) 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 ® 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. 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 Belgium Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2021 KRAMER LABORATORIES, INC. USA 729502 876 Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 4 fl oz (125mL) USA - 729503 Dist. by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2019 Kramer Laboratories, Inc. Made in Belgium USA - 696868 LOT EXP BUY 2 AND SAVE! Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 2 Bottles: 7 fl oz (200 mL) each Total 14 fl oz (400 mL) Use Nizoral ® Anti-Dandruff just twice a week to control your dandruff symptoms. 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. 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 Belgium Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2021 KRAMER LABORATORIES, INC. value packs xxx

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Stop use and ask a doctor if rash appears condition worsens or does not improve in 2-4 weeks

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on scalp that is broken or inflamed if you are allergic to ingredients in this product

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? call 1-800-824-4894

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes if product gets into eyes, rinse thoroughly with water

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a doctor before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

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. Source: OpenFDA, Healthporta Drugs API