Medicated Callus Removers Patch
FDA Label NDC 56104-913

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America Inc for the product Medicated Callus Removers (NDC 56104-913). 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, uses, warnings, do not use, stop use and ask a doctor if, 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

Uses

  • for the removal of 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 on any area that is infected or reddened

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 affected area and dry thoroughly
  • if necessary, cut medicated patch to fit callus
  • carefully adhere medicated patch direclty over callus
  • cover medicated patch with pad
  • after 48 hours, remove medicated patch
  • repeat this 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

Other Information

  • store between 15° to 30°C (59°F and 86°F)
  • avoid surrounding skin when applying medicated patch

Inactive Ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Questions?

call 1-866-964-0939

Principal Display Panel

premier
solutions

Medicated
CALLUS
REMOVERS

SALICYLIC ACID 40% / CALLUS REMOVER

MAXIMUM STRENGTH
Effective callus removal treatment
Protects against pressure & friction

6 Pads

4 Medicated Patches

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