Iristar Anti dandruff Shampoo. by Eubizrival LLC 83462-018 Complete

Iristar Anti dandruff Shampoo. by

Drug Labeling and Warnings

Iristar Anti dandruff Shampoo. by is a Otc medication manufactured, distributed, or labeled by Eubizrival LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IRISTAR ANTI DANDRUFF SHAMPOO.- ketoconazole shampoo lotion/shampoo 
Eubizrival LLC

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83462-018 Complete

Active Ingredient

Ketoconazole 1% w/w

Purpose

Anti Dandruff Shampoo

Use

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

Warnings

For external use only

Do not use

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

When Using

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

Stop Use

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

Ask Doctor

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

Keep Oot Of Reach Of Children

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

Directions

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

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

Inactive ingredients

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

IRISTAR ANTI DANDRUFF SHAMPOO. 
ketoconazole shampoo lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83462-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
PANTHENOL (UNII: WV9CM0O67Z)
PALM KERNEL OIL (UNII: B0S90M0233)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83462-018-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/29/2024	04/16/2025

Labeler - Eubizrival LLC (036572203)

Establishment
Name	Address	ID/FEI	Business Operations
Eubizrival LLC		036572203	label(83462-018) , manufacture(83462-018)

Revised: 4/2025

Document Id: 32e14094-059f-96d4-e063-6294a90ad9d7

34390-5

Set id: 14c8fce2-2aaf-b70b-e063-6394a90a4cfc

Version: 2

Effective Time: 20250416