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

Identifiers & Packaging

Marketing Status

NDA Active Since 2022-06-16 Until 2025-10-31

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

benzyl alcohol, BHT, blue 1, citric

acid, cocamide MEA, fragrance, glycol distearate, hydrochloric

acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium

benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium

hydroxide, sodium laureth sulfate, tetrasodium EDTA, water

Questions Or Comments?

call 1-800-824-4894

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^®

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.

Use Nizoral^® Anti-Dandruff just

twice a week to control 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 Canada

Distributed by:

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

USA

© 2022 KRAMER

LABORATORIES, INC.

Lot:

Exp:

P819B46100

Nizoral^®

Anti-Dandruff

KETOCONAZOLE 1%

ANTI-DANDRUFF SHAMPOO

CONTROLS

fungus that can cause dandruff

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)

P819H46000

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)

P809H45000

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

11 fl oz (325mL)

P829H47000

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

14 fl oz (400 mL)

P839H48000

SAMPLE

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

0.4 fl oz (12 mL)

Sample Not For Sale

Nizoral^®

Anti-Dandruff

KETOCONAZOLE 1%

ANTI-DANDRUFF SHAMPOO

VALUE SIZE - TWO 11 OZ BOTTLES

Anti-Dandruff

Shampoo

CLINICALLY PROVEN

to control flaking, scaling and

itching from dandruff

CONTROLS

fungus that can cause dandruff

CLEAN

fresh scent

2 Bottles: 11 fl oz (325 mL) each

Total 22 fl oz (650 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.

Anti-Dandruff

Shampoo

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

© 2023 KRAMER

LABORATORIES, INC.

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

19 fl oz (562mL)

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.

Use Nizoral^® Anti-Dandruff

just twice a week to control

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 Canada

Distributed by:

Kramer Laboratories, Inc.

Bridgewater, NJ 08807

USA

© 2025 KRAMER

LABORATORIES, INC.

P192B14000

Lot:

Exp:

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)

benzyl alcohol, BHT, blue 1, citric

acid, cocamide MEA, fragrance, glycol distearate, hydrochloric

acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium

benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium

hydroxide, sodium laureth sulfate, tetrasodium EDTA, water

Questions Or Comments? (Questions or comments?)

call 1-800-824-4894

Principal Display Panel (PRINCIPAL DISPLAY PANEL)