SALICYLIC ACID- medicated callus removers extra thick patch

Salicylic acid by

Drug Labeling and Warnings

Salicylic acid by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active ingredient

Salicylic acid 40%

Purpose

Callus remover

Use

• 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, 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 area 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 corn is removed)
• may soak corn in warm water for 5 minutes to assist in removal

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

Premier Value

Extra Thick
CALLUS REMOVERS

Salicylic acid

• Callus removal treatment
• Relieves against pressure & pain

4 MEDICATED PATCHES/4 PADS

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
medicated callus removers extra thick patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-230
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: 68016-230-04	4 in 1 PACKAGE; Type 0: Not a Combination Product	02/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	02/12/2018

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - Premier Brands of America (063849780)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Brands of America		080051232	relabel(68016-230) , repack(68016-230)

Establishment
Name	Address	ID/FEI	Business Operations
Alchemix Corporation		615263956	manufacture(68016-230)