Pureskin Wart Remover Gel by Stellans Inc. 83565-010 Completed

Pureskin Wart Remover Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURESKIN WART REMOVER GEL- pureskin wart remover gel gel 
Stellans Inc.

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83565-010 Completed

Active Ingredient

Salicylic Acid 17%

Purpose

Wart Remover

Use

Plantar Warts, Flat Warts, Common Warts

Warnings

For external use only.

Do not use

if you are diabetic, have poor blood circulation, or are allergic to this product
if you are pregnant or breast-feeding
on face, eye, genitals, mucous membranes, or healthy skin.
on moles, birthmarks, and warts with hair growing from them
on irritated, infected, or reddened skin

When Using

Flush with water immediately if it gets into your eyes

Stop Use

and ask a doctor if discomfort persists.

Ask Doctor

If you are pregnant, breast-feeding, or have any underlying conditions.

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a poison Control Center immediately.

Directions

1. Wash affected area, may soak the wart with warm water for 5 minutes.
2. Dry it thoroughly.
3. Apply a small drop to cover each wart.
4. Let dry and repeat this procedure once or twice daily until the wart is removed.

Other information

Close the cap tightly and keep away from heat above 104°F.

Inactive ingredients

Water, Sophora Flavescens, Prunus Mume (sieb.), Cnidium Monnieri (L.) Cuss, Crocus Sativus L., Gleditsia Sinensis Lam., Cortex Dictamni, Borneol, Kochia Scoparia Whole

Questions

www.pureskinsupport.com, info@pureskinsupport.com

PRINCIPAL DISPLAY PANEL

PURESKIN WART REMOVER GEL 
pureskin wart remover gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83565-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	17 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
PRUNUS MUME WHOLE (UNII: 3RSQ38B1JI)
GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)
WATER (UNII: 059QF0KO0R)
CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)
BORNEOL (UNII: M89NIB437X)
BASSIA SCOPARIA WHOLE (UNII: 240G38P85Z)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
CROCUS SATIVUS WHOLE (UNII: Z5C927G4XF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83565-010-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M028	07/15/2024	09/09/2024

Labeler - Stellans Inc. (111157321)

Establishment
Name	Address	ID/FEI	Business Operations
Stellans Inc.		111157321	manufacture(83565-010) , label(83565-010)

Revised: 9/2024

Document Id: 21ad0b6e-9511-7c13-e063-6394a90a3827

34390-5

Set id: 1d460b95-c4e7-81b8-e063-6294a90a5df1

Version: 2

Effective Time: 20240909