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

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83462-018

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

1

IRISTAR ANTI DANDRUFF SHAMPOO. 
ketoconazole shampoo lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83462-018-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03203/29/2024
Labeler - Eubizrival LLC (036572203)
Establishment
NameAddressID/FEIBusiness Operations
Eubizrival LLC036572203label(83462-018) , manufacture(83462-018)

Revised: 3/2024
Document Id: 14c8fce2-2ab0-b70b-e063-6394a90a4cfc
Set id: 14c8fce2-2aaf-b70b-e063-6394a90a4cfc
Version: 1
Effective Time: 20240329
 
Eubizrival LLC