Nizoral Shampoo
FDA Label NDC 55505-233

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 55505-233). 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

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,
hydrochloric acid, sodium hydroxide, blue 1

Questions Or Comments?

call 1-800-824-4894

K0524

Principal Display Panel

NEW!
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

© 2024 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

P238B1500

Lot:

Exp:         YYYY-MM

400ml Carton (Nizoral 400ml)

400ml Carton (Nizoral 400ml)

* Please review the disclaimer below.