FDA.reportPublic FDA data

85593-033-01

Manufacturer
Guangzhou ChuanMa International Trading Co.,Ltd.
Effective date
2026-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:25

Label at a glance#

ProductAnti Dandruff
Active ingredientKETOCONAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ketoconazole 1%

OTC - PURPOSE SECTION

Anti Dandruff

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

WARNINGS SECTION

For external use only

INDICATIONS & USAGE SECTION

For best results, follow these stepscarefully:1.Wet hair and scalp thoroughly with
lukewarm water.
2.Apply a sufficient amount of shampoo to
generate a rich lather.
3.Gently massage the lather into your scalp
and hair.4.Leavethe latheron the scalp for3-5minutes. This contact time is crucialforthemedication to work effectively.5.Rinse thoroughly with water.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Aqua, Sodium Laureth Sulfate, Cocamide DEA,Sodium Chloride, Cocamidopropyl Betaine,Ammonium LaurylSulfate, Ketoconazole,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar HydroxypropyltrimoniumChloride, C12-13 Pareth Lactate, CitricAcid, C11-15 Pareth-9, Trideceth-12, Sodium Benzoate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

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

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
85593-03385593-033-01

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
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEMVW5LK6LFTIACT
C12-13 ALKYL LACTATE9GLX7JL13MIACT
CITRIC ACID2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
C11-15 PARETH-9U6S376X80DIACT
AMINOPROPYL DIMETHICONE (2000 MPA.S)K3CD5CYV6SIACT
COCAMIDE DEA92005F972DIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRIDECETH-12YFY3KG5Y7OIACT
SODIUM CHLORIDE451W47IQ8XIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
AQUA059QF0KO0RIACT
SODIUM LAURETH-2 SULFATEZZQ59TY3KGIACT
KETOCONAZOLER9400W927IACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-03-14full-release2026-06-01 01:50:17

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.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
ndc (package): 85593-033-01
ndc (product): 85593-033
ndc11 (package): 85593003301
spl id: 55a48fc6-194b-66ea-e063-6294a90a3501
spl set id: 4cfe234c-49c0-18e8-e063-6294a90a0b1d

Reported adverse events (FAERS/openFDA)#

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