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Nizoral Shampoo Prescribing Information

Package insert / product label
Generic name: ketoconazole
Dosage form: shampoo
Drug class: Topical antifungals

Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.

Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo

Uses
controls flaking, scaling and itching associated with dandruff

Warnings
For external use only

Do not use

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

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

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

Keep out of the reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Nizoral Shampoo Dosage and Administration

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

Storage and Handling

  • 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

Carton Label

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

200 mL front

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

125 mL front

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

325ml  Front

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

400 mL front

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

12 mL Sample

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.

add new image 2x325 mL
NIZORAL
ketoconazole shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-196
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole10 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol (UNII: LKG8494WBH)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Coco Monoethanolamide (UNII: C80684146D)
Glycol Distearate (UNII: 13W7MDN21W)
Hydrochloric Acid (UNII: QTT17582CB)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) (UNII: 0L414VCS5Y)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Cocoyl Sarcosinate (UNII: 1R9DUY89CZ)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Edetate Sodium (UNII: MP1J8420LU)
Water (UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-196-331 in 1 CARTON06/16/2022
1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55505-196-401 in 1 CARTON06/16/2022
2200 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55505-196-641 in 1 CARTON06/16/2022
3325 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55505-196-651 in 1 CARTON06/16/2022
4400 mL in 1 CARTON; Type 0: Not a Combination Product
5NDC:55505-196-474 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2024
6NDC:55505-196-722 in 1 CARTON12/01/2023
6325 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02031006/16/2022
Labeler - Kramer Laboratories (122720675)