Package Label.Principal Display Panel
Drug Facts
Wart Remover Salicylic Acid 18% Liquid
FDA Label NDC 85248-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Wart Remover Salicylic Acid 18% (NDC 85248-001). 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 package label.principal display panel, otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - when using, otc - ask doctor/pharmacist, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients Purpose
Salicylic acid 18.0%…............................……………………………..…..………………….Wart Remover
Otc - Purpose
Wart Remover
Indications & Usage
Uses
- for removal of common and plantar warts
- the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface
- the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern
- use this product only if you are sure that the skin condition is a wart
Otc - Do Not Use
Do not use
- if you are diabetic or have poor blood circulation
- on irritated skin or any area that is infected or reddened
- on moles, birthmarks, hairy warts, genital warts, or warts on the face or mucous membranes
Otc - When Using
When using this product
- avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.
- avoid inhaling vapors
Otc - Ask Doctor/Pharmacist
Stop and ask a doctor if discomfort persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Warnings
Warnings
For external use only
------------------------------------------------------------------------------------------------------------------------------------
Flammable
- keep away from fire or flame
- cap bottle tightly and store at room temperature away from heat
Dosage & Administration
Directions
- wash the affected area and soak the wart in warm water for 5 minutes
- dry the area thoroughly
- carefully apply one drop at a time with applicator to sufficiently cover each wart
- allow it to dry
- repeat once or twice daily as needed until the wart is removed, for up to 12 weeks
Other Safety Information
keep the bottle tightly closed and store at room temperature 68-99°F (20-37℃)
Inactive Ingredient
Inactive ingredients Borneol, Glycerin, Podofilox, Polyethylene Glycol, Water
* Please review the disclaimer below.
