PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM- seborrheic dermatitis eczema cream cream 
Stellans Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Ketoconazole 0.5%

Purpose

seborrheic dermatitis, eczema

Use

USES for relief of skin itching, irritation, redness, flaking and scaling associated with seborrheic dermatitis, eczema, folliculitis, or psoriasis, and to help prevent symptom recurrence.

Warnings

For external use only.

Do not use

On open skin wounds
In children less than 6 months of age.

When Using

Avoid contact with eyes. If contact occurs, rinse the eyes immediately with water.
Keep out of the reach of young children.

Stop Use

Condition worsens or doesn’t improve after regular use of the product as directed.
You become pregnant, or are planning to become pregnant, while using the product.

Ask Doctor

Condition worsens or doesn’t improve after regular use of the product as directed.
You become pregnant, or are planning to become pregnant, while using the product.

Keep Out Of Reach Of Children

Keep out reach of children.

Directions

Clean the affected area with warm water and dry thoroughly.
Apply a thin layer over the affected area two to three times daily and gently massage it 2 minutes, repeat 3 to 5 days after symptoms disappear to control recurrence.
Children should use it under the supervision of adults.

Other information

store at 20-25 ℃

Inactive ingredients

Glycerin, Sodium Hyaluronate, Salicylic Acid,
Rhinacanthus Nasutus Leaf, Heba Violae, Euphorbia Hirta L., Murraya Exotica L., Mentha Canadensis L., Cortexdictamnil, Sophora Flavescens Root, Cnidium Monnieri (L.) Cusson, Smilax Glabra Rhizome, Mosla Cavaleriei H.Lv.,, Phellodendron Amurense Rupr., Fischereuphorbia Root, Gleditsia Sinensis Thorn, Kochia Scoparia, Chlorhexidine Acetate, Stemona Tuberosa Lour

Questions

info@pureskinsupport.com
www.pureskinsupport.com

PRINCIPAL DISPLAY PANEL

0102

PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM 
seborrheic dermatitis eczema cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-001
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
RHINACANTHUS NASUTUS LEAF (UNII: 97OQD55S9I)  
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
MOSLA CAVALERIEI WHOLE (UNII: 05O8B64OS2)  
GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY)  
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
EUPHORBIA HIRTA LEAF (UNII: 243K8QF0MS)  
MURRAYA PANICULATA LEAFY TWIG (UNII: VO9X9681W9)  
MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L)  
CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)  
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
SMILAX GLABRA TUBER (UNII: PES3YXA3LR)  
STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316)  
PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L)  
EUPHORBIA FISCHERIANA ROOT (UNII: R4DRG4762Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
VIOLA ADUNCA WHOLE (UNII: 26Z8E4RZ3Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83565-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00507/07/2023
Labeler - Stellans Inc. (111157321)
Establishment
NameAddressID/FEIBusiness Operations
Stellans Inc.111157321label(83565-001) , manufacture(83565-001)

Revised: 7/2023
Document Id: fff56b94-b74f-039a-e053-6294a90a3918
Set id: fff56b94-b74e-039a-e053-6294a90a3918
Version: 1
Effective Time: 20230708
 
Stellans Inc.