NIZORAL- ketoconazole shampoo 
Kramer Laboratories

----------

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

  • 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

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

  • 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 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.

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

© 2020 KRAMER
LABORATORIES, INC.

USA
XXXXXX
875

55505-191-40carton

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)

55505-191-40front

Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA
© 2020 Kramer Laboratories, Inc.
Made in Belgium

USA - XXXXXX

LOT

EXP
 

55505-191-40back

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®
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 

© 2020 KRAMER
LABORATORIES, INC.

USA
XXXXXX 
876

55505-191-33carton

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)

55505-191-33front

Dist. by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA 
© 2020 Kramer Laboratories, Inc. 
Made in Belgium 

USA - XXXXXX

LOT

EXP

55505-191-33back
NIZORAL 
ketoconazole shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-191
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-191-401 in 1 CARTON01/07/201908/01/2021
1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55505-191-33125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/07/201908/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02031001/07/201908/01/2021
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Pharmaceutica NV370005019analysis(55505-191) , api manufacture(55505-191) , manufacture(55505-191) , pack(55505-191)

Revised: 1/2021
Document Id: 681ce4eb-f27d-443d-a6b1-1debb812678c
Set id: f64110c2-201e-4e29-b76c-591db50e7bd7
Version: 4
Effective Time: 20210107
 
Kramer Laboratories