FDA Label for Nizoral
View Indications, Usage & Precautions
Nizoral Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use.
Otc - 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 |
|
| children under 12 years |
|
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
* Please review the disclaimer below.