Drug Facts

Composition & Product

Active Ingredients

Ketoconazole (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

NDA Active Since 2024-11-01

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

controls flaking, scaling and itching associated with dandruff

Description

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

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Section 53414-9

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

Section 55105-1

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

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

Do Not Use

on scalp that is broken or inflamed
if you are allergic to ingredients in this product

Other Information

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

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 Or Comments?

call 1-800-824-4894

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

When Using This Product

avoid contact with eyes
if product gets into eyes, rinse thoroughly with water

Stop Use and Ask A Doctor If

rash appears
condition worsens or does not improve in 2-4 weeks

Structured Label Content

Indications and Usage (34067-9)

Uses

controls flaking, scaling and itching associated with dandruff

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

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

Do Not Use (Do not use)

on scalp that is broken or inflamed
if you are allergic to ingredients in this product

Other Information (Other information)

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

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

Questions Or Comments? (Questions or comments?)

call 1-800-824-4894

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

When Using This Product (When using this product)

avoid contact with eyes
if product gets into eyes, rinse thoroughly with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash appears
condition worsens or does not improve in 2-4 weeks

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses controls flaking, scaling and itching associated with dandruff", "34071-1": "Warnings For external use only", "50565-1": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a doctor before use.", "55105-1": "Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo", "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", "Do not use": "on scalp that is broken or inflamed if you are allergic to ingredients in this product", "Other information": "store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date", "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 or comments?": "call 1-800-824-4894", "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", "When using this product": "avoid contact with eyes if product gets into eyes, rinse thoroughly with water", "Stop use and ask a doctor if": "rash appears condition worsens or does not improve in 2-4 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information