Active Ingredient
Salicylic acid 40 %
Txl Active Wart Corn Remover Bandage Patch
FDA Label NDC 83818-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Txl Active Wart Corn Remover Bandage (NDC 83818-009). 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, Corn and Small Callus Remover
Use
For the removal of common warts, plantar warts, corns, and small calluses.
Warnings
For external use only.
Do Not Use
On open wounds, irritated or infected skin,skin tags, moles, facial warts, genital warts,Molluscum, or milia (white bumps), or mucous membranes,
When Using
Avoid contact with eyes or healthy skin. In case of accidental contact, rinse thoroughly with water.
Stop Use
Redness, irritation, swelling, or pain persists or worsens.The wart, corn, or callus does not improve within the expected treatmentperiod (up to 12 weeks).
Ask Doctor
Redness, irritation, swelling, or pain persists or worsens.The wart, corn, or callus does not improve within the expected treatmentperiod (up to 12 weeks).
Keep Oot Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control Center right away.
Directions
1.Wash the affected area with soap and warm water. Rinse thoroughly and drycompletely.
2. Select the appropriate size pad (large or small) that fits the wart, corn, orsmall callus.
3. Apply the medicated center directly over the wart, corn, or small callus.
Avoid covering healthy skin.4. Use the provided PU adhesive bandage to secure the pad in place, ensuring
it stays firmly attached.5. Leave the pad in place for 24 hours. After 24 hours, remove the pad andclean the affected area.
6. Repeat the application process daily as needed until the wart, corn, or callusis removed.
7. Do not use it for more than 12 weeks unless directed by a doctor.
Other Information
store between 59° and 86°F (15°C and 30°C)
Inactive Ingredients
Hard paraffin, lanolin, phenol
Questions
Call 1-914-875-2018
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