PURESKIN ANTI DANDRUFF SHAMPOO.- pureskin anti dandruff shampoo shampoo 
Stellans Inc.

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83565-009

Active Ingredient

Ketoconazole 0.5%

Purpose

Anti Dandruff

Use

controls flaking, scaling and itching associated with dandruff

Warnings

For external use only.

Do not use

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

When Using

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

Stop Use

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

Ask Doctor

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

Keep Out Of Reach Of Children

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

Directions

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

store at 15-25 ℃

Inactive ingredients

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

Questions

info@pureskinsupport.com
www.pureskinsupport.com

PRINCIPAL DISPLAY PANEL

1

PURESKIN ANTI DANDRUFF SHAMPOO. 
pureskin anti dandruff shampoo shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WITCH HAZEL (UNII: 101I4J0U34)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PURSLANE (UNII: M6S840WXG5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
ROSEMARY (UNII: IJ67X351P9)  
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TEA TREE OIL (UNII: VIF565UC2G)  
LICORICE (UNII: 61ZBX54883)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SERINE (UNII: 452VLY9402)  
ARGININE (UNII: 94ZLA3W45F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83565-009-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03206/11/2024
Labeler - Stellans Inc. (111157321)
Establishment
NameAddressID/FEIBusiness Operations
Stellans Inc.111157321label(83565-009) , manufacture(83565-009)

Revised: 6/2024
Document Id: 1a991c67-8ec5-69cf-e063-6394a90acb62
Set id: 1a991c67-8ec4-69cf-e063-6394a90acb62
Version: 1
Effective Time: 20240611
 
Stellans Inc.