FDA.reportPublic FDA data

83565-009

Manufacturer
Stellans Inc.
Effective date
2024-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:00:48

Label at a glance#

ProductPureskin anti dandruff shampoo.
Active ingredientKETOCONAZOLE
Label structure14 sections

Dosage and administration

wet hair thoroughly apply shampoo, gently lather and massage for 2 minutes, and then rinse thoroughly. use 2-3 times per week for up to 8 weeks or as directed by a doctor.

Storage and handling

store at 15-25 ℃

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 0.5%

Purpose

OTC - PURPOSE SECTION

Anti Dandruff

Use

INDICATIONS & USAGE SECTION

controls flaking, scaling and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or inflamed scalp.
if you are pregnant or breat-feeding.
in children less than 12 years old.

When Using

OTC - WHEN USING SECTION

avoid contact with eyes
if product gets into eyes, rinse thoroughly with water

Stop Use

OTC - STOP USE SECTION

irritation or rash occurs
condition worsens or does not improve in 2-4 weeks

Ask Doctor

OTC - ASK DOCTOR SECTION

• irritation or rash occurs
• condition worsens or does not improve in 2-4 weeks

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help ot contact a Poison Control Center (1-800-222-1222)right away.

Directions

DOSAGE & ADMINISTRATION SECTION

wet hair thoroughly
apply shampoo, gently lather and massage for 2 minutes, and then rinse thoroughly.
use 2-3 times per week for up to 8 weeks or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

store at 15-25 ℃

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua
Glycerin
Sodium Cocoyl Isethionate
Propylene Glycol
Aloe Vera
Citric Acid
Rosemary
Tea Tree Oil
Witch Hazel
Chinese Mugwort Leaf
Licorice
Ethylhexylglycerin
Purslane
Sodium Chloride
Serine
Arginine
Coconut Oi

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
83565-00983565-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PURSLANEM6S840WXG5IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
ROSEMARYIJ67X351P9IACT
ARTEMISIA ARGYI LEAF2JYC99Q0WZIACT
COCONUT OILQ9L0O73W7LIACT
GLYCERINPDC6A3C0OXIACT
KETOCONAZOLER9400W927IACTIB
TEA TREE OILVIF565UC2GIACT
LICORICE61ZBX54883IACT
SODIUM CHLORIDE451W47IQ8XIACT
SERINE452VLY9402IACT
ARGININE94ZLA3W45FIACT

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
21acfac2-6770-657b-e063-6394a90aeab51a991c67-8ec4-69cf-e063-6394a90acb622024-09-09WarningsExact identifier
spl set id: 1a991c67-8ec4-69cf-e063-6394a90acb62

Reported adverse events (FAERS/openFDA)#

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