NIZORAL- ketoconazole shampoo

Nizoral by

Drug Labeling and Warnings

Nizoral by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

PREGNANCY OR BREAST FEEDING

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

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

INGREDIENTS AND APPEARANCE

NIZORAL 
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)	Ketoconazole	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-233-65	400 mL in 1 CARTON; Type 0: Not a Combination Product	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020310	11/01/2024

Labeler - Kramer Laboratories (122720675)