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, 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

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

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

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

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

SAMPLE

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

0.4 fl oz (12 mL)

Sample Not For Sale

Nizoral®

Anti-Dandruff

KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO 

VALUE SIZE - TWO 11 OZ BOTTLES

Anti-Dandruff
Shampoo

CLINICALLY PROVEN
to control flaking, scaling and
itching from dandruff

CONTROLS
fungus that can cause dandruff

CLEAN
fresh scent

2 Bottles: 11 fl oz (325 mL) each
Total 22 fl oz (650 mL)

Use Nizoral® Anti-Dandruff
just twice a week to control
your dandruff symptoms.

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.

Anti-Dandruff
Shampoo

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

© 2023 KRAMER
LABORATORIES, INC.

INGREDIENTS AND APPEARANCE

NIZORAL 
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-196
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: 55505-196-33	1 in 1 CARTON	06/16/2022
1		125 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55505-196-40	1 in 1 CARTON	06/16/2022
2		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 55505-196-64	1 in 1 CARTON	06/16/2022
3		325 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 55505-196-65	1 in 1 CARTON	06/16/2022
4		400 mL in 1 CARTON; Type 0: Not a Combination Product
5	NDC: 55505-196-47	4 mL in 1 PACKET; Type 0: Not a Combination Product	03/01/2024
6	NDC: 55505-196-72	2 in 1 CARTON	12/01/2023
6		325 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020310	06/16/2022

Labeler - Kramer Laboratories (122720675)