FDA.reportPublic FDA data

85593-128-01 ANTI-DANDRUFF- ketoconazole shampoo

Manufacturer
Guangzhou ChuanMa International Trading Co.,Ltd.
Effective date
2026-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-08 02:01:33

Label at a glance#

ProductANTI-DANDRUFF
Active ingredientKETOCONAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purpose
Ketoconazole 1% w/w....Anti-dandruff shampoo

OTC - PURPOSE SECTION

Relieves ItchingControls FlakingScalp Clarifying
Seborrheic Dermatitis Care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

WARNINGS SECTION

For external use only. Avoid contact witheyes. Ifcontact occurs, rinse thoroughlywithwater.

DOSAGE & ADMINISTRATION SECTION

Use every 3-4 days for up to 8 weeks. Afterthat, use only asneeded to control dandruff.

INDICATIONS & USAGE SECTION

For best results, follow these steps
carefully:lukewarm water.
1.Wet hair and scalp thoroughly with
2.Applya sufficient amount of shampooto
generate a rich lather.3.Gently massage the lather into your scalp
and hair.
4.Leave the lather on the scalp for 3-5medication to work effectively.5.Rinse thoroughly with water.
minutes. This contact time is crucialfor the

INACTIVE INGREDIENT SECTION

Aqua, Sodium Laureth Sulfate, CocamideDEA, Sodium Chloride, CocamidopropylBetaine, Ammonium Lauryl Sulfate,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate,Aminopropyl Dimethicone,Hydroxypropyl GuarHydroxypropyltrimonium Chloride, C12-13Pareth Lactate, CitricAcid, C11-15 Pareth-9,Trideceth-12, Sodium Benzoate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85593-128 information85593-128 information

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
85593-12885593-128-01

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
AQUA059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDE DEA92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEMVW5LK6LFTIACT
CITRIC ACID2968PHW8QPIACT
C11-15 PARETH-9U6S376X80DIACT
TRIDECETH-12YFY3KG5Y7OIACT
SODIUM BENZOATEOJ245FE5EUIACT
C12-13 PARETH-99BXD858P37IACT
AMINOPROPYL DIMETHICONE (1000 MPA.S)P4P48I53XHIACT

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
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsExact identifier
ndc (package): 85593-128-01
ndc (product): 85593-128
ndc11 (package): 85593012801
spl id: 5ac93feb-eb6e-7563-e063-6294a90ad2e0
spl set id: 5ac93feb-eb6d-7563-e063-6294a90ad2e0

Reported adverse events (FAERS/openFDA)#

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