Pureskin Tinea Treatment by Stellans Inc. 83565-005 Completed

Pureskin Tinea Treatment by

Drug Labeling and Warnings

Pureskin Tinea Treatment by is a Otc medication manufactured, distributed, or labeled by Stellans Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURESKIN TINEA TREATMENT- pureskin tinea treatment cream 
Stellans Inc.

----------

83565-005 Completed

Active Ingredient

Thuja Occidentalis 6x HPUS

Purpose

Tinea

Use

For relief of itching, scaling, redness, and discomfort caused by tinea versicolor, ringworm(tinea corporis), and athlete’s foot(tinea pedis)

Warnings

For external use only.
Do not use it on children under two years of age unless directed by a physician.
Avoid contact with the eyes.

Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.

Stop using and consult a physician if
Irritation occurs.
No improvement over 4 weeks.

Do not use

Do not use it on children under two years of age unless directed by a physician.
Avoid contact with the eyes.

When Using

Avoid contact with the eyes.

Keep out of reach of children.

Stop Use

Irritation occurs.
No improvement over 4 weeks.

Ask Doctor

Irritation occurs.
No improvement over 4 weeks.

Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.

Directions

Clean affected skin with warm water and dry thoroughly.
Apply a thin layer of cream over the affected area twice daily(morning and night), or as directed by a physician.
Continue using it for one week to prevent recurrence.

Other information

store at 15-25 ℃

Inactive ingredients

Glycerin, Menthol, Vitamin E, Aloe Vera, Coconut Oil, Rhinacanthus Nasutus, Herba Violae, Euphorbia Hirta L., Murraya Exotica L., Mentha, Canadensis L., Cortex Dictamni, Sophora Flavescens

Questions

info@pureskinsupport.com
www.pureskinsupport.com

PRINCIPAL DISPLAY PANEL

PURESKIN TINEA TREATMENT 
pureskin tinea treatment cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83565-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MURRAYA PANICULATA LEAFY TWIG (UNII: VO9X9681W9)
MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
RHINACANTHUS NASUTUS LEAF (UNII: 97OQD55S9I)
EUPHORBIA HIRTA LEAF (UNII: 243K8QF0MS)
MENTHOL (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
COCONUT OIL (UNII: Q9L0O73W7L)
VIOLA ADUNCA WHOLE (UNII: 26Z8E4RZ3Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83565-005-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	10/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/04/2023	09/09/2024

Labeler - Stellans Inc. (111157321)

Establishment
Name	Address	ID/FEI	Business Operations
Stellans Inc.		111157321	label(83565-005) , manufacture(83565-005)

Revised: 9/2024

Document Id: 21ad0a80-8a00-cf57-e063-6294a90ab341

34390-5

Set id: 06e77370-10c0-6354-e063-6294a90ad20f

Version: 3

Effective Time: 20240909