MedPath

Ragkun WART REMOVER

Approved
Approval ID

3ccea52e-c900-8ffb-e063-6294a90ae75b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Jiashen International Trading Co., Ltd.

DUNS: 989067943

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84867-021
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
BORNEOLInactive
Code: M89NIB437X
Classification: IACT
SALICYLIC ACIDActive
Quantity: 5 g in 100 mL
Code: O414PZ4LPZ
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PODOFILOXInactive
Code: L36H50F353
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

avold contact wth eyes. f product gets intothe eye, ush with water for 15minutes. avoidinhalng vapors cap tighly and store at roomtemperature away from heat

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Salicylic acid 5%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Borneol

Glycerin

Podofilox

Water
Polyethylene Glycol

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/20/2025

Keep out of Reach of children

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Plantar wart

Corn

Calluses

Flat warts
Common wart

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings
For external use only. Flammable.Keep awayfrom fire and flame.Do not use on irritatedskin or on any area that is infected orreddened·on moles, birthmarks, warts withhair growing from them, genital warts or wartson the face or mucous membranes*if you havediabetes or poor blood circulation.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

wash affected area·may soak wart in warmwater for 5 minutes· dry area thoroughly· bysqueezing tube gently, apply one drop at a timeto sufficiently cover each wart·let dry·repeatthis procedure once or twice daily as needed(until wart is removed)for up to 12 weeks

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/20/2025

store at room temperature*avoid excessiveheat 37°C (99°F)·skin discoloration may accurduring or after use· wipe the tip of the tubewith a paper towel between uses

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Ragkun WART REMOVER - FDA Drug Approval Details