Active Ingredient
Salicylic acid 5%
Butterflys Tear Wart Remover Liquid
FDA Label NDC 85248-216
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 Butterflys Tear Wart Remover (NDC 85248-216). 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 and corn remover
Use
the removal of skin tags, corns, calluses, plantar warts, flat warts, common warts (less than 5 mm in size).
Warnings
·For external use only.
·Keep away from heat or flame.
Do Not Use
·On irritated skin or on any area that is infected or reddened.
·On moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.
·If you have diabetes or poor blood circulation.
When Using
·Keep out of eyes, ears, and mouth.
·If product gets in eyes, flush with water for 15 minutes.
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, get medical help or contact a Poison Control Center right away.
Directions
·Wash the affected area.
·Soak the wart in warm water for 5 minutes and dry it thoroughly.
·Apply one drop at a time with the applicator to cover the skin tag completely.
·Allow to dry, use self‑adhesive cushioning pads to cover the wart if desired.
·Repeat this process once or twice daily as needed, for up to 12 weeks, until the wart is removed. (Note: For external use, and cannot be applied to healthy skin).
Other Information
Store between 20° to 25°C (68° to 77°F) and keep tightly closed.
Inactive Ingredients
Purified Water, Polyvinyl Alcohol, Chitosan, Ethanol, Glycerin, Laurocapram, Collodion, Nitrocellulose.
Principal Display Panel
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