Pureskin Seborrheic Dermatitis Eczema Cream by Stellans Inc. 83565-001 Completed

Drug Details [pdf]

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

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83565-001 Completed

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

PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM
seborrheic dermatitis eczema cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83565-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 83565-001-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	07/07/2023	09/09/2024

Labeler - Stellans Inc. (111157321)

Name	Address	ID/FEI	Business Operations
Establishment
Stellans Inc.		111157321	label(83565-001) , manufacture(83565-001)

Revised: 9/2024

Document Id: 21acf19d-d04e-97ca-e063-6294a90a5e41

Set id: fff56b94-b74e-039a-e053-6294a90a3918

Version: 2

Effective Time: 20240909