1% ketoconazole anti dandruff

Manufacturer
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:40:20

Label at a glance#

Product1% ketoconazole anti dandruff
Active ingredientKETOCONAZOLE
Label structure12 sections

Dosage and administration

adults and children 12 years and over:①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Repeat ③use 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

①store at 20°C to 25°C (68*F-77°F) ②see bottom panel for expiration date

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff shampoo

Use

INDICATIONS & USAGE SECTION

controls flaking, scaling and itching from dandruff

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on scalp that is broken or inflamed

if there is a known sensitivity to any of the ingredients

OTC - WHEN USING SECTION

avoid contact with eyes
in case of such contact, rinse well with water

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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:①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Repeat
③use 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

①store at 20°C to 25°C (68*F-77°F)
②see bottom panel for expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Dea, Dimethicone, Sodium Chloride, Glycol Distearate,
Amino BispropyI Dimethicone, Fragrance, Polyquaternium-10, Carbomer, Azelaic Acid, L aurtrimonium Chloride, Guar
Hydroxypropyltrimonium Chloride, Methylisothiazolinone, Citric Acid, Coco/Oleamidopropyl Betaine, Dodecylbenzene Sulfonic
Acid, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen, Triethanolamine, Phenoxyethanol, AO1

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

undefinedundefinedundefinedundefinedundefinedundefinedundefinedundefined

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240812ketoconazole 1 % Medicated ShampooPSN1
240812ketoconazole 10 MG/ML Medicated ShampooSCD1
240812ketoconazole 1 % Medicated ShampooSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84558-005-011% ketoconazole anti dandruff200 mL in 1 BOTTLESHAMPOO2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84558-0051% KETOCONAZOLE ANTI DANDRUFF (1% KETOCONAZOLE ANTI DANDRUFF SHAMPOO) SHAMPOO [GUANGZHOU YUSONG FINE CHEMICLS CO., LTD]11 package rows20241206_286c5fbb-74c0-7de3-e063-6394a90a0973.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84558-00584558-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

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
286c5b25-54b2-6fc8-e063-6394a90a90d1286c5fbb-74c0-7de3-e063-6394a90a09732024-12-03WarningsExact identifier
spl id: 286c5b25-54b2-6fc8-e063-6394a90a90d1
spl set id: 286c5fbb-74c0-7de3-e063-6394a90a0973

Reported adverse events (FAERS/openFDA)#

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