Drug Facts

Composition & Product

Active Ingredients

Ketoconazole (1 g)

Inactive Ingredients

Benzyl Alcohol Butylated Hydroxytoluene Citric Acid Monohydrate Coco Monoethanolamide Fd&c Blue No. 1 Fd&c Yellow No. 5 Glycol Distearate Hydrochloric Acid Hypromellose, Unspecified Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Sodium Benzoate Sodium Chloride Sodium Cocoyl Sarcosinate Sodium Hydroxide Sodium Laureth-3 Sulfate Edetate Sodium Water

Identifiers & Packaging

Marketing Status

NDA Active Since 2025-10-01

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

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

Questions Or Comments?

call 1-800-824-4894

Dist. by:

Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA

©2025 Kramer Laboratories, Inc. Made in Canada

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

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, 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

Questions Or Comments? (Questions or comments?)

call 1-800-824-4894

Principal Display Panel (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

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

[{"name": "Ketoconazole", "unii": "R9400W927I", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Benzyl Alcohol", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Butylated Hydroxytoluene", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Citric Acid Monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Coco Monoethanolamide", "unii": "C80684146D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Fd&C Blue No. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Fd&C Yellow No. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycol Distearate", "unii": "13W7MDN21W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrochloric Acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hypromellose, Unspecified", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw)", "unii": "0L414VCS5Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Chloride", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Cocoyl Sarcosinate", "unii": "1R9DUY89CZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Laureth-3 Sulfate", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Edetate Sodium", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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": "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", "Questions or comments?": "call 1-800-824-4894 Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA ©2025 Kramer Laboratories, Inc. Made in Canada", "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", "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