Active Ingredient
Salicylic acid 17%
Spesolskii Wart Corn Callus Remover Liquid
FDA Label NDC 87556-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Best Green Limited for the product Spesolskii Wart Corn Callus Remover (NDC 87556-003). 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 active ingredient, purpose, uses, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wart remover
Uses
For the removal of common warts and plantar warts, corns and calluses.
Common warts have a rough "cauliflower-like" surface and are easily recognizable. Plantar warts are located on the soles of the feet, tender to touch, with interrupted footprint patterns.
Warnings
For external use only. Keep away from fire.
Do Not Use
·On irritated, infected, reddened or broken skin.
·On moles, birthmarks, hairy warts, genital warts, facial warts or mucous membranes.
·If you have diabetes or poor blood circulation.
When Using
Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water for 15 minutes. Not for ingestion. Keep tightly capped. Store at room temperature away from heat.
If pregnant or breastfeeding, consult a healthcare professional before use.
Stop Use
Persistent discomfort, skin irritation, redness or rash occur.
Ask Doctor
Persistent discomfort, skin irritation, redness or rash occur.
Keep Out Of Reach Of Children
If swallowed, seek immediate medical attention or contact a Poison Control Center.
Directions
1.Wash the affected area. Soak the wart in warm water for about 5 minutes (optional).
2.Pat the area dry thoroughly.
3.Use a cotton swab to apply sufficient liquid to fully cover each wart.
A film forms and covers the wart within one minute.
4.Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks.
Other Information
Store at room temperature.
Avoid excessive heat above 37°C (99°F).
Keep container tightly closed.
Skin discoloration may occur during or after use.
Inactive Ingredients
Water, Polyvinylpyrrolidone (PVP), 1,3-Dimethyl-2-imidazolidinone (DMI), Glycerol, Propylene Glycol (PG), Phenoxyethanol.
Principal Display Panel
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