FDA.reportPublic FDA data

packeg

Manufacturer
Guangzhou ChuanMa International Trading Co.,Ltd.
Effective date
2026-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-25 01:02:57

Label at a glance#

ProductAnti Dandruff
Active ingredientKETOCONAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ketoconazole 1%
Purpose Anti-dandruff

OTC - PURPOSE SECTION

Helps control flaking and itching associated with dandruff

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical
help orcontact a Poison Control Center right away.

WARNINGS SECTION

Stop use and ask a doctor if
rash occurs condition worsens or does not improve after
regular use as directed
aIf pregnant or breast-feeding, ask a doctor before use.
Keep out of reach of children. If swallowed, get medical
help or contacta Poison Control Centerright away.

DOSAGE & ADMINISTRATION SECTION

Repeat.use every 3-4 days forup to 8 weeks or as directedby a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Aqua, Sodium Laureth Sulfate, Cocamide DEA, SodiumChloride, Cocamidopropyl Betaine, Ammonium LaurylSulfate, Polyquaternium-10, Fragrance, Phenoxyethanol,PEG-7 Glyceryl Cocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar Hydroxypropyltrimonium Chloride,C12-13 Pareth-3, Lactate, Citric Acid, C11-15 Pareth-9,Trideceth-12, Sodium Benzoate.

INDICATIONS & USAGE SECTION

Directions
adults and children 12 years and older: wet hairthoroughly,apply shampoo, generously lather, rinsethoroughly. Repeat.use every 3-4 days for up to 8 weeks or as directedby a doctor. Then use only as needed to controldandruff.

packeg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85593-12185593-121-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
KETOCONAZOLER9400W927IACTIB
AQUA059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDE DEA92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
AMINOPROPYL DIMETHICONE (1000 MPA.S)P4P48I53XHIACT
HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEMVW5LK6LFTIACT
C12-13 PARETH-3DMC6N3419LIACT
LACTIC ACID33X04XA5ATIACT
CITRIC ACID2968PHW8QPIACT
C11-15 PARETH-9U6S376X80DIACT
TRIDECETH-12YFY3KG5Y7OIACT
SODIUM BENZOATEOJ245FE5EUIACT

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.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
ndc (package): 85593-121-01
ndc (product): 85593-121
ndc11 (package): 85593012101
spl id: 599f2cce-0c28-d425-e063-6394a90a1565
spl set id: 599f2cce-0c27-d425-e063-6394a90a1565

Reported adverse events (FAERS/openFDA)#

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