FDA Label for Nizoral

View Indications, Usage & Precautions

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
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL

Nizoral Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose

Active ingredient	Purpose
Ketoconazole 1% w/w	Anti-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

* Please review the disclaimer below.

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