PED X CALLUS REMOVERS, EXTRA THICK MEDICATED- salicylic acid patch PED X CALLUS REMOVERS, MEDICATED- salicylic acid patch

Ped X Callus Removers, Medicated by

Drug Labeling and Warnings

Ped X Callus Removers, Medicated by is a Otc medication manufactured, distributed, or labeled by Pacific World Corporation. 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

Do not use

• on irritated skin or any area that is infected or reddened
• if you are a diabetic
• if you have poor blood circulation.

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 disk to fit callus before applying.
• after 48 hours remove the medicated disk.
• 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 59°F-86°F (15°C-30°C)

Inactive ingredient

Vinyl acetate.

Questions?

1(541)-476-3178, 8 am to 5 pm (M–F), PST

PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Extra Thick

pedx™

new!

Extra Thick Medicated

Callus Removers

dissolving relief from tough

CALLUSES

6 cushions
4 medicated disks

PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Medicated

pedx™

new!

Medicated

Callus Removers

dissolving relief from tough

CALLUSES

6 cushions
4 medicated disks

INGREDIENTS AND APPEARANCE

PED X CALLUS REMOVERS, EXTRA THICK MEDICATED 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60193-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)	Salicylic acid	4 mg

Inactive Ingredients
Ingredient Name	Strength
Vinyl acetate (UNII: L9MK238N77)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60193-401-02	4 in 1 CELLO PACK
1	NDC: 60193-401-01	1 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	09/01/2007

PED X CALLUS REMOVERS, MEDICATED 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60193-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)	Salicylic acid	4 mg

Inactive Ingredients
Ingredient Name	Strength
Vinyl acetate (UNII: L9MK238N77)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60193-400-02	4 in 1 CELLO PACK
1	NDC: 60193-400-01	1 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	09/01/2007

Labeler - Pacific World Corporation (089693097)