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

KEEP OUT OF REACH OF CHILDREN

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 between 35° and 86°F (2° and 30°C)
• protect from light
• protect from freezing
• see top panel for lot number and expiration date

Inactive ingredients

acrylic acid polymer (carbomer 1342), butylated hydroxytoluene, cocamide MEA, FD&C Blue #1, fragrance, glycol distearate, polyquaternium-7, quaternium-15, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide and/or hydrochloric acid, sodium laureth sulfate, tetrasodium EDTA, water

Questions or comments?

call 1-800-824-4894

PRINCIPAL DISPLAY PANEL

NON-PRESCRIPTION STRENGTH

NDC: 55505-191-40

Nizoral®

A-D KETOCONAZOLE SHAMPOO 1%

Anti-Dandruff Shampoo

CONTROLS FLAKING, SCALING AND ITCHING

The Freedom Will Go To Your Head

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.
233 Mt. Airy Road,
Suite 100, Basking Ridge
NJ 07920

1-800-824-4894

© 2019 Kramer Laboratories, Inc.

KRAMER
LABORATORIES


Kramer Laboratories, Inc.
233 Mt. Airy Road,
Suite 100, Basking Ridge
NJ 07920

Made in Belgium
US Patent No. 5,456,851


USA
692133
875

NON-PRESCRIPTION STRENGTH

NDC: 55505-191-40

Nizoral®

A-D KETOCONAZOLE SHAMPOO 1%

Anti-Dandruff Shampoo

CONTROLS FLAKING, SCALING AND ITCHING

7 FL OZ (200 mL)

USA - 688136

Dist. by: Kramer Laboratories, Inc.
Basking Ridge, NJ 07920 USA
© 2019 Kramer Laboratories, Inc.

Made in Belgium
US Patent No. 5,456,851

USA - 688036

LOT

EXP
 

NON-PRESCRIPTION STRENGTH

NDC: 55505-191-33

Nizoral®

A-D KETOCONAZOLE SHAMPOO 1%

Anti-Dandruff Shampoo

CONTROLS FLAKING, SCALING AND ITCHING

The Freedom Will Go To Your Head

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.
233 Mt. Airy Road,
Suite 100, Basking Ridge
NJ 07920

1-800-824-4894

© 2019 Kramer Laboratories, Inc.

KRAMER
LABORATORIES


Kramer Laboratories, Inc.
233 Mt. Airy Road,
Suite 100, Basking Ridge
NJ 07920

Made in Belgium
US Patent No. 5,456,851


USA
688039
876

NON-PRESCRIPTION STRENGTH

NDC: 55505-191-33

Nizoral®

A-D KETOCONAZOLE SHAMPOO 1%

Anti-Dandruff Shampoo

CONTROLS FLAKING, SCALING AND ITCHING

4 FL OZ (125 mL)

USA - 688137

Dist. by: Kramer Laboratories, Inc.
Basking Ridge, NJ 07920 USA
© 2019 Kramer Laboratories, Inc.

Questions or comments?
call 1-800-824-4894

Made in Belgium
US Patent No. 5,456,851

USA - 688131

LOT

EXP
 

INGREDIENTS AND APPEARANCE

NIZORAL 
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-191
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
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Coco Monoethanolamide (UNII: C80684146D)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Glycol Distearate (UNII: 13W7MDN21W)
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) (UNII: 0L414VCS5Y)
Quaternium-15 (UNII: E40U03LEM0)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Cocoyl Sarcosinate (UNII: 1R9DUY89CZ)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)
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: 55505-191-40	1 in 1 CARTON	01/07/2019
1		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55505-191-33	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2019

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

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Pharmaceutica NV		370005019	analysis(55505-191) , api manufacture(55505-191) , manufacture(55505-191) , pack(55505-191)