Salicylic Acid Patch
FDA Label NDC 70000-0333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Salicylic Acid (NDC 70000-0333). 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, otc - ask doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

​Active Ingredient

Salicylic acid 40%

Purpose

Callus remover

Use

  • for the removal of hard calluses
  • relieves pain by removing calluses

Warnings

For external use only.

Do Not Use

  • if you are a diabetic
  • if you have poor blood circulation
  • on irritated skin or any area that is infected or reddened

Otc - Ask Doctor

If discomfort persists see your doctor or podiatrist

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • if necessary, cut medicated patch to fit callus
  • apply adhesive side down of medicated patch onto callus
  • cover medicated patch with pad
  • after 48 hours, remove medicated patch
  • repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
  • may soak callus in warm water for 5 minutes to assist in removal
  • continued wearing of pad (without patch) will help prevent recurrence of calluses

Other Information

store between 15°C to 30°C (59°F to 86°F)

Inactive Ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

call 1-866-964-0939

Principal Display Panel

LEADER

Medicated

Callus

Removers
with Salicylic Acid 40%

  • Effective Callus Removal Treatment
  • Protect Against Pressure and Pain
  • 4 MEDICATED PATCHES/ 6 PROTECTIVE PADS

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