VISCO-GEL MEDICATED ROUND CALLUS REMOVERS- salicylic acid disc

Visco-Gel Medicated Round Callus Removers by

Drug Labeling and Warnings

Visco-Gel Medicated Round Callus Removers by is a Otc medication manufactured, distributed, or labeled by PEDIFIX, INC., AKRON. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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-PEDIFIX (733-4349)

PRINCIPAL DISPLAY PANEL - 4 Disk Blister Pack

PediFix ®
The Podiatrist's Choice
Since 1885

NEW!

Visco-GEL ®
Medicated Round
Callus Removers
With Salicylic Acid

Instant Pain Relief!

• Safely Removes Calluses
• Adhesive Gel Cushions
  & Protects

Relief
Spot

Maximum
Strength

Washable & Reusable
Effective for Weeks

4 Medicated Disks
4 Cushions

INGREDIENTS AND APPEARANCE

VISCO-GEL MEDICATED ROUND CALLUS REMOVERS 
salicylic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68927-0819
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: 68927-0819-1	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 - PEDIFIX, INC. (122271935)

Establishment
Name	Address	ID/FEI	Business Operations
PEDIFIX, INC.		122271935	label(68927-0819) , pack(68927-0819)

Establishment
Name	Address	ID/FEI	Business Operations
AKRON		186569323	manufacture(68927-0819)