SALICYLIC ACID- medicated callus removers patch

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by LEADER/ Cardinal Health 110, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​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

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

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
medicated callus removers patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	40 mg  in 4

Inactive Ingredients
Ingredient Name	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990)
VINYL ACETATE (UNII: L9MK238N77)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0333-1	4 in 1 PACKAGE; Type 0: Not a Combination Product	02/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	02/21/2018

Labeler - Cardinal Health (097537435)