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

benzyl alcohol, BHT, citric acid,
cocamide MEA, FD&C Blue 1, FD&C Yellow 5, 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

Dist. by:
Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA
©2025 Kramer Laboratories, Inc.             Made in Canada

PRINCIPAL DISPLAY PANEL

Center panel

NEW SCENT!

Nizoral®

Anti-Dandruff

KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO 

PEPPERMINT
COMPLEX + 
TEA TREE ESSENCE

Anti-Dandruff
Shampoo 

CLINICALLY PROVEN
to control flaking, scaling and
itching from dandruff

CONTROLS
fungus that can cause dandruff

REFRESHING
peppermint complex
+ tea tree essence

14 fl oz (400 mL)

right panel

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.

left panel

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

© 2025 KRAMER
LABORATORIES, INC.



P221B16000

Lot:

Exp:         YYYY-MM

 Nizoral® 

Anti-Dandruff

KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO

PEPPERMINT
COMPLEX +
TEA TREE ESSENCE

CLINICALLY PROVEN
to control flaking scaling
and itching from dandruff

CONTROLS
fungus that can cause dandruff

REFRESHING
peppermint complex
+ tea tree essence

14 fl oz (400 mL)

P221H13000

P221H14000

LOT
EXP YYYY-MM

INGREDIENTS AND APPEARANCE

NIZORAL 
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)	Ketoconazole	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Benzyl Alcohol (UNII: LKG8494WBH)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Coco Monoethanolamide (UNII: C80684146D)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Fd&C Yellow No. 5 (UNII: I753WB2F1M)
Glycol Distearate (UNII: 13W7MDN21W)
Hydrochloric Acid (UNII: QTT17582CB)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) (UNII: 0L414VCS5Y)
Sodium Benzoate (UNII: OJ245FE5EU)
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: 55505-232-65	400 mL in 1 CARTON; Type 0: Not a Combination Product	10/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020310	10/01/2025

Labeler - Kramer Laboratories (122720675)