POAGCI Ketoconazole VCP-KAD001

Manufacturer
Vince (Guangzhou) Cosmetics Co., Ltd.
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:24:21

Label at a glance#

ProductPOAGCI Ketoconazole VCP-KAD001
Active ingredientKETOCONAZOLE
Label structure14 sections

Indications and uses

controls flaking, scaling and itching associated with dandruff

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1% w/w

Purpose

OTC - PURPOSE SECTION

Anti-dandruff shampoo

Uses

INDICATIONS & USAGE SECTION

controls flaking, scaling and itching associated with dandruff

Warnings

WARNINGS SECTION

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 produc

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 - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

adults and children 12 years and over

DOSAGE & ADMINISTRATION SECTION

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 dandruf

children under 12 years

DOSAGE & ADMINISTRATION SECTION

ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Sodium Lauryl Sulfate, Dimethicone, Dimethiconol, Disodium Laureth Sulfosuccinate, Zinc Pyrithione, Phenoxyethanol, Fragrance, Sodium Cocoyl Alaninate, Caprylyl/Capryl Glucoside, Guar Hydroxypropyltrimonium Chloride, Salicylic Acid, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyquaternium-67, Glycerin, Sodium Hydroxide, Cetrimonium Chloride, Benzoic Acid, Acrylamidopropyltrimonium Chloride/Acrylamide Copolymer, Piroctone Olamine, Laureth-23, Tea-Dodecylbenzenesulfonate, Sodium Polynaphthalenesulfonate, DMDM Hydantoin, Sodium Benzoate, Cellulose Gum, Ethylhexylglycerin, CI 16255

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84745-002-01 Label84745-002-01 Label

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
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84745-002-01POAGCI Ketoconazole VCP-KAD001100 mL in 1 BOTTLELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84745-002POAGCI KETOCONAZOLE VCP-KAD001 (KETOCONAZOLE) LIQUID [VINCE (GUANGZHOU) COSMETICS CO., LTD.]11 package rows20241013_2435001f-82a8-a781-e063-6394a90a9628.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84745-00284745-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
2435001f-82a9-a781-e063-6394a90a96282435001f-82a8-a781-e063-6394a90a96282024-10-11WarningsExact identifier
spl id: 2435001f-82a9-a781-e063-6394a90a9628
spl set id: 2435001f-82a8-a781-e063-6394a90a9628

Reported adverse events (FAERS/openFDA)#

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