Otc - Purpose
| Active ingredient | Purpose |
| Ketoconazole 1% w/w | Anti-dandruff shampoo |
Nizoral Shampoo
FDA Label NDC 55505-232
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Nizoral (NDC 55505-232). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, citric acid,
cocamide MEA, FD&C Blue 1, FD&C Yellow 5, fragrance, glycol
distearate, hydrochloric acid, hydroxypropyl methylcellulose,
polyquaternium-7, sodium benzoate, sodium chloride, sodium
cocoyl sarcosinate, sodium hydroxide, sodium laureth sulfate,
tetrasodium EDTA, water
Questions Or Comments?
call 1-800-824-4894
Dist. by:
Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA
©2025 Kramer Laboratories, Inc. Made in Canada
Principal Display Panel
Center panel
NEW SCENT!
Nizoral®
Anti-Dandruff
KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO
PEPPERMINT
COMPLEX +
TEA TREE ESSENCE
Anti-Dandruff
Shampoo
CLINICALLY PROVEN
to control flaking, scaling and
itching from dandruff
CONTROLS
fungus that can cause dandruff
REFRESHING
peppermint complex
+ tea tree essence
14 fl oz (400 mL)
right panel
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.
left panel
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 Canada
Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
USA
© 2025 KRAMER
LABORATORIES, INC.
P221B16000
Lot:
Exp: YYYY-MM
400 mL Carton (Carton)
Nizoral®
Anti-Dandruff
KETOCONAZOLE 1%
ANTI-DANDRUFF SHAMPOO
PEPPERMINT
COMPLEX +
TEA TREE ESSENCE
CLINICALLY PROVEN
to control flaking scaling
and itching from dandruff
CONTROLS
fungus that can cause dandruff
REFRESHING
peppermint complex
+ tea tree essence
14 fl oz (400 mL)
P221H13000
Front Label (Front Label)
P221H14000
LOT
EXP YYYY-MM
Back Label (Back Label)
* Please review the disclaimer below.
