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 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
Strengths
1 %
Quantities
400 ml
Treats Conditions
Uses Controls Flaking Scaling And Itching Associated With Dandruff

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0053076000221
UNII
R9400W927I
Packaging

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

Package Descriptions
  • 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

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 Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA ©2025 Kramer Laboratories, Inc. Made in Canada


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