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

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

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

Description

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

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

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

Do Not Use

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

Questions Or Comments?

call 1-800-824-4894

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Indications and Usage (34067-9)

Uses

controls flaking, scaling and itching associated with dandruff

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

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

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

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

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

call 1-800-824-4894

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"}