Wart Remover Plaster
FDA Label NDC 28691-0400

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmaplast Sae for the product Wart Remover (NDC 28691-0400). 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 drug facts, active ingredient, purpose, indications, warnings, otc - keep out of reach of children, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Salicyclic Acid 40% w/w

Purpose

Common and plantar wart, corn and callus remover

Indications

  • For removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface.
  • For the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.
  • For removal of corns and calluses
  • Relieves pain by removing corn and calluses.

Warnings

  • For external use only
  • Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.
  • If discomfort persists, see your doctor.
  • Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

Otc - Keep Out Of Reach Of Children

  • Keep this and all drugs out of the reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately

Directions

For removal Common and Plantar warts:

  • Wash affected area.
  • May soak wart in warm water for 5 minutes.
  • Dry area thoroughly.
  • Cut plaster to fit wart.
  • Apply medicated plaster.
  • Repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks.
  • For removal Corn and Calluses:

    • Wash affected area and dry thoroughly.
    • Cut plaster to fit corn/callus.
    • Apply medicated plaster.
    • After 48 hours remove the medicated plaster.
    • Repeat this procedure every 48 hours as needed for up to 14 days until corn/callus is removed.
    • May soak corn/callus in warm water for 5 minutes to assist in removal.

Inactive Ingredient

Rubber based adhesive

Questions?

+2034500264

Other

CURE-AID®

Common and plantar wart, corn and callus remover

  • 40% Salicylic Acid
  • Physician Recommended
  • Cut-to-Fit Pads
  • 20 pieces 50 x 72 mm

* Please review the disclaimer below.