Nizoral Shampoo
FDA Label NDC 55505-196

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Nizoral (NDC 55505-196). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredientPurpose
Ketoconazole 1% w/wAnti-dandruff shampoo

Indications & Usage

Uses 
controls flaking, scaling and itching associated with dandruff

Warnings

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

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 (7ozcarton)

Carton Label (7ozcarton)

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 (7ozfront)

200 mL Front (7ozfront)

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 (4ozfront)

125 mL Front (4ozfront)

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 (11ozfront)

325ml Front (11ozfront)

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 (14ozfront)

400 mL Front (14ozfront)

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