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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ped X™ Callus Removers

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 - Extra Thick

PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Medicated

pedx™

new!

Medicated

Callus Removers

dissolving relief from tough

CALLUSES

6 cushions
4 medicated disks

Principal Display Panel - 4 mg Patch Cello Pack - Medicated

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358F	09/01/2007

Labeler - Pacific World Corporation (089693097)

Revised: 10/2014

Document Id: 0d3afc45-2982-40b5-ac28-4f616a6cddae

Set id: 613cfe0b-8917-4226-a7eb-c6e150f23b9e

Version: 2

Effective Time: 20141017

Pacific World Corporation