Active Ingredient
Salicylic acid 17%
Spesolskii Wart Remover Cream
FDA Label NDC 87556-002
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 Remover Cream (NDC 87556-002). 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, use, 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
Use
For the removal of common warts, plantar warts, hand warts with rough, cauliflower-like appearance.
Warnings
For external use only. Avoid contact with eyes.
If product gets into eyes, rinse thoroughly with water for 15 minutes.
Do Not Use
·On irritated, infected, broken or reddened skin.
·If you are diabetic or have poor blood circulation.
·On birthmarks, hairy warts or moles.
When Using
If pregnant or breastfeeding, consult a healthcare professional before use.
Stop Use
Discomfort, persistent redness, irritation or rash occur.
Ask Doctor
Discomfort, persistent redness, irritation 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 for better results.
2.Pat the area dry thoroughly.
3.Apply a small amount of cream to fully cover each wart. Allow to dry completely.
4.Repeat twice daily as needed. Treatment may continue for up to 12 weeks.
Other Information
Store in a cool, dry shaded place.
Keep container tightly closed.
Inactive Ingredients
Water, Polyethylene Glycol, Glycerin, Borneol, Phenoxyethanol, Ethylhexylglycerin.
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