PEDI-QUICK ONE STEP CALLUS REMOVERS- salicylic acid plaster
PEDIFIX, INC.

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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Pedi-Quick One Step 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 Use only as directed

Do Not Use this product

on irritated skin, or on any area that is infected or reddened
if you are diabetic
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 five minutes, if desired. Dry thoroughly.
Remove bandage from backing
Apply with medicated area directly over callus
After 48 hours remove medicated bandage
Repeat procedure every 48 hours as needed (until callus is removed) for up to 14 days.

Other information Store between 59 o and 86 o F (15 o and 30 o C)

Inactive Ingredients Polyvinyl Alcohol, Acrylic Copolymer

Questions or Comments? CALL 1-800-Pedifix (733-4349)

Package Label

PEDI-QUICK ONE STEP CALLUS REMOVERS
salicylic acid plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68927-3295
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68927-3295-1	1 in 1 CONTAINER	07/07/2017
1		4 in 1 CELLO PACK
1		44.18 mg 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	part358B	07/07/2017

Labeler - PEDIFIX, INC. (122271935)

Registrant - PEDIFIX, INC. (122271935)

Name	Address	ID/FEI	Business Operations
Establishment
PEDIFIX, INC.		122271935	pack(68927-3295)

Name	Address	ID/FEI	Business Operations
Establishment
Akron Coating & Adhesive		186569323	manufacture(68927-3295)

Revised: 2/2019

Document Id: 81f2c495-817b-4165-e053-2a91aa0a67e1

Set id: c6b7e849-1328-4d77-a9f2-e04d0b4e873b

Version: 6

Effective Time: 20190215

PEDIFIX, INC.