83462-018

Manufacturer
Eubizrival LLC
Effective date
2024-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:51

Label at a glance#

ProductIristar Anti dandruff Shampoo.
Active ingredientKETOCONAZOLE
Label structure13 sections

Dosage and administration

adults and children 12 years and over • wet hair thoroughly • apply shampoo, generously lather, rinse thoroughly. Repeat • 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 old • Ask a doctor

Storage and handling

• store at 20°C to 25°C (68°F-77°F) • see top panel for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1% w/w

Purpose

OTC - PURPOSE SECTION

Anti Dandruff Shampoo

Use

INDICATIONS & USAGE SECTION

controls flaking, scaling and itching associated with dandruff
Warnings
For external use only

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on scalp that is damaged or inflamed
• if vou are allergic to ingredients in this product

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

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

Ask Doctor

OTC - ASK DOCTOR SECTION

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

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children
12 years and over
• wet hair thoroughly
• apply shampoo, generously lather, rinse thoroughly. Repeat
• 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 old • Ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at 20°C to 25°C (68°F-77°F)
• see top panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA, LAURYL GLUCOSIDE, PALM KERNELAMIDE DEA, GLYCERIN, COCAMIDOPROPYL BETAINE, SODIUM CHLORIDE, POTASSIUM COCOYL GLYCINATE, POTASSIUM COCOATE, PHENOXYETHANOL, DIMETHICONOL, ALLANTOIN, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROLYZED COLLAGEN, HYDROLYZED ELASTIN, PANTHENOL, CENTELLA ASIATICA EXTRACT, CITRIC ACID, DISODIUM EDTA, PARFUM, METHYLISOTHIAZOLINONE, METHYLCHLOROISOTHIAZOLINONE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83462-01883462-018-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
32e14094-059f-96d4-e063-6294a90ad9d714c8fce2-2aaf-b70b-e063-6394a90a4cfc2025-04-16WarningsExact identifier
spl set id: 14c8fce2-2aaf-b70b-e063-6394a90a4cfc

Reported adverse events (FAERS/openFDA)#

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