NIZORAL- ketoconazole shampoo 
Kramer Laboratories

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Drug Facts

Active ingredientPurpose
Ketoconazole 1%Anti-dandruff shampoo

Uses 
controls flaking, scaling and itching associated with dandruff

Warnings
For external use only

Do not use

When using this product

Stop use and ask a doctor if

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

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

Inactive ingredients

benzyl alcohol, BHT, blue 1, citric acid, cocamide MEA, fragrance, glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7, 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® 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.

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 Belgium

Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
USA

© 2022 KRAMER
LABORATORIES, INC.


USA
753769
875

200mL Carton

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)

USA -753767

200 mL front

Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA
© 2022 Kramer Laboratories, Inc.
Made in Belgium

USA - 753768

LOT

EXP

200 mL back

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)

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® 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.

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 Belgium

Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
USA

© 2022 KRAMER
LABORATORIES, INC.


USA
753764
876

125mL Carton

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)

USA -753765

125 mL  front

Dist. by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA
© 2022 Kramer Laboratories, Inc.
Made in Belgium

USA - 753766

LOT

EXP

125 ml back

BUY 2 AND SAVE!

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

2 Bottles: 7 fl oz (200 mL) each
Total 14 fl oz (400 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.

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 Belgium

Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807 USA

© 2021 KRAMER
LABORATORIES, INC.

Nizoral Twin Pack 2 x.200ml

value packs xxx

Nizoral Value packs 2 x 200 mL + 125 mL
NIZORAL 
ketoconazole shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Hypromelloses (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-192-401 in 1 CARTON01/07/2019
1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55505-192-331 in 1 CARTON11/01/2019
2125 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55505-192-572 in 1 CARTON11/01/2019
31 in 1 CARTON
3200 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55505-192-592 in 1 CARTON11/01/2019
4325 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02031001/07/2019
Labeler - Kramer Laboratories (122720675)

Revised: 12/2023
Document Id: 787642a1-831e-42f4-9ac0-8cff31b910ae
Set id: 63840ff7-d447-4f4e-a05b-1fbed2da8a25
Version: 6
Effective Time: 20231211
 
Kramer Laboratories