NIZORAL- ketoconazole shampoo

Nizoral by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Ketoconazole 1%: 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 Chloride, Sodium Cocoyl Sarcosinate, Sodium Hydroxide, Sodium Laureth Sulfate, Tetrasodium EDTA, Water

Questions?

call 1-800-824-4894

PRINCIPAL DISPLAY PANEL

NEW LOOK

NDC: 55505-192-40

Nizoral®A-D
KETOCONAZOLE
ANTI-DANDRUFF
SHAMPOO 1%

Anti-Dandruff
Shampoo

CONTROLS
FLAKING
SCALING
ITCHING

7 FL OZ (200 mL)

Before use read all label information. If you have a drug reaction, contact a doctor and report it by calling or writing:

Kramer Laboratories, Inc.
Bridgewater, NJ 08807

Questions
1-800-824-4894

www.nizoral.com

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

Made in Belgium

© 2019 Kramer Laboratories, Inc.

USA
692002
875

NEW LOOK

NDC: 55505-192-40

Nizoral®A-D

KETOCONAZOLE
ANTI-DANDRUFF
SHAMPOO 1%

Anti-Dandruff
Shampoo

CONTROLS
FLAKING
SCALING
ITCHING

7 FL OZ (200 mL)

USA - 692003

Distributed by:
Kramer Laboratories, Inc. 
Bridgewater, NJ 08807
nizoral.com

© 2019 Kramer Laboratories, Inc.
Made in Belgium

USA - 690341

LOT

EXP
 

NEW LOOK

NDC: 55505-192-33

Nizoral®A-D

KETOCONAZOLE
ANIT-DANDRUFF
SHAMPOO 1%

Anti-Dandruff
SHAMPOO

CONTROLS
FLAKING
SCALING
ITCHING

4 FL OZ (125 mL)

Before use read all label information. If you have a drug reaction, contact a doctor and report it by calling or writing:

Kramer Laboratories, Inc.
Bridgewater, NJ 08807

Questions
1-800-824-4894

www.nizoral.com

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

Made in Belgium

© 2019 Kramer Laboratories, Inc.


USA
695004
876

NEW LOOK

NDC: 55505-192-33

Nizoral®A-D

KETOCONAZOLE
ANTI-DANDRUFF
SHAMPOO 1%

Anti-Dandruff 
SHAMPOO

CONTROLS
FLAKING
SCALING
ITCHING

4 FL OZ (125 mL)

USA - 692005

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

nizoral.com

® 2019 Kramer Laboratories, Inc.
Made in Belgium

USA - 690335

LOT

EXP

INGREDIENTS AND APPEARANCE

NIZORAL 
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-192
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-192-40	1 in 1 CARTON	01/07/2019
1		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55505-192-33	1 in 1 CARTON	11/01/2019
2		125 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 55505-192-57	2 in 1 CARTON	11/01/2019
3		1 in 1 CARTON
3		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 55505-192-59	2 in 1 CARTON	11/01/2019
4		325 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020310	01/07/2019

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Pharmaceutica NV		370005019	analysis(55505-192) , api manufacture(55505-192) , manufacture(55505-192) , pack(55505-192)