WALGREENS MEDICATED CALLUS REMOVERS- salicylic acid disc

Walgreens Medicated Callus Removers by

Drug Labeling and Warnings

Walgreens Medicated Callus Removers by is a Otc medication manufactured, distributed, or labeled by WALGREENS Co., PEDIFIX, INC., PEDIFIX, AKRON. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Salicylic acid 40%

Purpose

Callus remover

Uses

• For the removal of calluses
• relieves pain by removing calluses

Warnings

For external use only   Use only as directed

Do Not Use

• if you are diabetic
• on irritated, broken or infected skin
• if you have poor blood circulation

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 immediately.

Directions

• Wash affected area. Soak in warm water for 5 minutes if desired.
  Dry thoroughly
• Apply medicated disk directly over callus
• Cover medicated disk with gel pad
• After 48 hours, remove medicated disk
• Repeat procedure every 48 hours as needed (until callus is removed) for up to 14 days

Other Information

Store between 59° and 86°F (15° and 30°C)

Inactive Ingredients

Polyvinyl Alcohol, Acrylic Copolymer

Questions or Comments?

CALL: 1-800-925-4733

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DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 4 Disk Blister Pack

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED ‡

NEW

MEDICATED

Gel Callus
Removers

Salicylic Acid 40%

• Callus removal treatment
• Cushions against pressure & pain
• Self-sticking, washable & reusable
• Effective for weeks

4
MEDICATED
DISKS | 4 CUSHIONS

INGREDIENTS AND APPEARANCE

WALGREENS MEDICATED CALLUS REMOVERS 
salicylic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	17.67 mg  in 44.18 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0819-01	1 in 1 CONTAINER	06/01/2013
1		4 in 1 CELLO PACK
1		44.18 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	06/01/2013

Labeler - WALGREENS Co. (008965063)

Registrant - PEDIFIX, INC. (122271935)

Establishment
Name	Address	ID/FEI	Business Operations
PEDIFIX		122271935	pack(0363-0819) , label(0363-0819)

Establishment
Name	Address	ID/FEI	Business Operations
AKRON		186569323	manufacture(0363-0819)