Otc - Active Ingredient
Salicylic acid 5%
Ragkun Wart Remover Cream
FDA Label NDC 84867-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiashen International Trading Co., Ltd. for the product Ragkun Wart Remover (NDC 84867-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - keep out of reach of children, otc - purpose, warnings, indications & usage, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Borneol
Glycerin
Podofilox
Polyethylene Glycol
Water
Otc - Keep Out Of Reach Of Children
Keep out of Reach of children
Otc - Purpose
Plantar wart
Corn
Calluses
Flat warts
Common wart
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
Indications & Usage
avoid contact with eyes. lf product gets intothe eye,flush with water for 15minutes.·avoidinhaling vapors· cap tightly and store at roomtemperature away from heat
Dosage & Administration
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
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
Package Label.Principal Display Panel
Labeling (84867 019 01)
* Please review the disclaimer below.
