Nizoral KETOCONAZOLE KRAMER LABORATORIES FDA Approved Uses controls flaking, scaling and itching associated with dandruff
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Substance Ketoconazole
Route
TOPICAL
Applications
NDA020310
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo
Inactive Ingredients
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
Strengths
1 %
Quantities
400 ml
Treats Conditions
Uses Controls Flaking Scaling And Itching Associated With Dandruff

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
R9400W927I
Packaging

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

Package Descriptions
  • 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

Overview

Uses controls flaking, scaling and itching associated with dandruff

Indications & Usage

Uses controls flaking, scaling and itching associated with dandruff

Dosage & 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

Warnings & Precautions
Warnings For external use only
Purpose

Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo

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

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.

Storage & Handling

Other information store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date

Questions

Questions or comments? call 1-800-824-4894


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