Active Ingredient
Salicylic acid 5%
Terracalm Wart Removal Gel
FDA Label NDC 87786-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Terracalm Wart Removal Gel (NDC 87786-007). 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, which have a rough, cauliflower-like appearance.
Warnings
For external use only-
Avoid contact with eyes.
If the product gets into the eyes, rinse with water for 15 minutes.Avoid inhaling vapors.
Do Not Use
Don't use on irritated or infected skin, or reddened areas.
If you are diabetic or have poor blood circulation, consult a doctor before use.
Don't use on birthmarks, warts with hair growth or moles.
When Using
If pregnant or breast-feeding,consult a health professional before use.
Stop Use
Stop use and ask a doctor if discomfort persists.
Ask Doctor
Stop use and ask a doctor if discomfort persists.
Keep Out Of Reach Of Children
If swallowed, seek immediate medical help or contact a Poison Control Center.
Directions
Wash the affected area.(Soaking in warm water for 5 minutes may help.)
Dry thoroughly.
Apply a small amount to cover each wart. Let it dry.
Repeat twice daily as needed, for up to 12 weeks.
Inactive Ingredients
Water, Polyethylene Glycol,Glycerin, Borneol, Methylparaben, Chlorhexidine
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