FDA.reportPublic FDA data

87681-009 Gemächlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos

Manufacturer
Guangzhou Xinhongda Trading Service Co., Ltd.
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-31 05:10:24

Label at a glance#

ProductGemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos
Active ingredientKETOCONAZOLE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

KETOCONAZOLE 1%

OTC - PURPOSE SECTION

Anti-dandruff shampoos

INDICATIONS & USAGE SECTION

Controls flaking, scaling and itching associated with dandruff.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION


on scalp that is broken or inflamed.
if you are allergic to ingredients in this product.

OTC - WHEN USING SECTION


When using this products. Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if
rash appears.
condition worsens or does not improve in 2-4 weeks.

If pregnant or breast-feeding, ask a doctor before use.

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 righta way.

DOSAGE & ADMINISTRATION SECTION


For adults and children 12 years and older:
1. Wet hair thoroughly.
2. Apply shampoos, generously lather, rinse thoroughly. Repeat.
3. Use 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.

INACTIVE INGREDIENT SECTION

WATER
SODIUM LAUROYL SARCOSINATE
COCAMIDOPROPYL BETAINE
PARFUM
GLYCERYL CAPRYLATE
GLYCERYL LAURATE
PHENOXYETHANOL
LAURYL LACTATE
CITRIC ACID
POLYQUATERNIUM-10
DISODIUM EDTA
HYDROLYZED RHODOPHYCEAE EXTRACT
BUTYLENE GLYCOL
1,2-HEXANEDIOL
PENTYLENE GLYCOL
PROPANEDIOL
CAPRYLHYDROXAMIC ACID
ETHYLHEXYLGLYCERIN
BIOTIN
POTASSIUM HYDROXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

label

Products#

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87681-00987681-009-01, 87681-009-02

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
WATER059QF0KO0RIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL LAURATEY98611C087IACT
PHENOXYETHANOLHIE492ZZ3TIACT
LAURYL LACTATEG5SU0BFK7OIACT
CITRIC ACID2968PHW8QPIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PENTYLENE GLYCOL50C1307PZGIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BIOTIN6SO6U10H04IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

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
5792eff5-632f-3664-e063-6394a90a8ae35792eff5-632e-3664-e063-6394a90a8ae32026-07-27WarningsExact identifier
spl id: 5792eff5-632f-3664-e063-6394a90a8ae3
spl set id: 5792eff5-632e-3664-e063-6394a90a8ae3

Reported adverse events (FAERS/openFDA)#

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