FDA.reportPublic FDA data

Nizoral

Manufacturer
Kramer Laboratories | Janssen Pharmaceutica NV
Effective date
2021-01-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:57:35

Label at a glance#

ProductNizoral
Active ingredientKetoconazole
Label structure12 sections

Dosage and administration

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

Storage and handling

store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Ketoconazole 1%Anti-dandruff shampoo

INDICATIONS & USAGE SECTION

Uses controls flaking, scaling and itching associated with dandruff

WARNINGS SECTION

Warnings
For external use only

Do not use

OTC - DO NOT USE SECTION

  • on scalp that is broken or inflamed
  • if you are allergic to ingredients in this product

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • if product gets into eyes, rinse thoroughly with water

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • rash appears
  • condition worsens or does not improve in 2-4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • store at 20°C to 25°C (68°F-77°F)
  • see top panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call 1-800-824-4894

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
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
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
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
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
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
55505-191-33back

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-191-40ML - Milliliter55505-191fd884180-6a09-4c64-8b36-46031ea06bfb12019-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-19155505-191-40, 55505-191-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
KetoconazoleR9400W927IACTIB
Benzyl AlcoholLKG8494WBHIACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Fd&C Blue No. 1H3R47K3TBDIACT
Citric Acid Monohydrate2968PHW8QPIACT
Coco MonoethanolamideC80684146DIACT
Glycol Distearate13W7MDN21WIACT
Hydrochloric AcidQTT17582CBIACT
Hypromellose, Unspecified3NXW29V3WOIACT
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw)0L414VCS5YIACT
Sodium Chloride451W47IQ8XIACT
Sodium Cocoyl Sarcosinate1R9DUY89CZIACT
Sodium Hydroxide55X04QC32IIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
Edetate SodiumMP1J8420LUIACT
Water059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020310-001NIZORAL ANTI-DANDRUFFKETOCONAZOLE1%SHAMPOO / TOPICALRLD, RS1997-10-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1084e616aacf4f…
2026-08-18 06:07:402026-07N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-103f01610625f2…
2019-09-15 20:21 UTC2019-09N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N020310-001NIZORAL A-D1%SHAMPOO / TOPICALRLD, RS1997-10-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020310-001NIZORAL ANTI-DANDRUFF1%SHAMPOO / TOPICALRLD, RS1997-10-10f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
681ce4eb-f27d-443d-a6b1-1debb812678cf64110c2-201e-4e29-b76c-591db50e7bd72021-01-07WarningsExact identifier
spl id: 681ce4eb-f27d-443d-a6b1-1debb812678c
spl set id: f64110c2-201e-4e29-b76c-591db50e7bd7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.