FDA.reportPublic FDA data

87681-014 Cysndra Ketoconazole 1% Medicated Shampoos

Manufacturer
Guangzhou Xinhongda Trading Service Co., Ltd.
Effective date
2026-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:43:31

Label at a glance#

ProductCysndra Ketoconazole 1% Medicated 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


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

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

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
WATER
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

label1label1

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
87681-01487681-014-01, 87681-014-02

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
PENTYLENE GLYCOL50C1307PZGIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PROPANEDIOL5965N8W85TIACT
CITRIC ACID2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
KETOCONAZOLER9400W927IACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
LAURYL LACTATEG5SU0BFK7OIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
BIOTIN6SO6U10H04IACT

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
55ee7358-dfc2-b600-e063-6394a90a49d855ee7358-dfc1-b600-e063-6394a90a49d82026-07-06WarningsExact identifier
spl id: 55ee7358-dfc2-b600-e063-6394a90a49d8
spl set id: 55ee7358-dfc1-b600-e063-6394a90a49d8

Reported adverse events (FAERS/openFDA)#

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