PEDI-QUICK ONE STEP CALLUS REMOVERS- salicylic acid plaster

Pedi-Quick One Step Callus Removers by

Drug Labeling and Warnings

Pedi-Quick One Step Callus Removers by is a Otc medication manufactured, distributed, or labeled by PEDIFIX, INC., Akron Coating & Adhesive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Salicylic Acid 40%

PURPOSE

Purpose

Callus remover

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only  Use only as directed

DO NOT USE

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

ASK DOCTOR/PHARMACIST

If discomfort persists, see your doctor or podiatrist

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control center immediately

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive Ingredients Polyvinyl Alcohol, Acrylic Copolymer

QUESTIONS

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

Package Label

INGREDIENTS AND APPEARANCE

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

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, UNSPECIFIED (UNII: 532B59J990)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	07/07/2017

Labeler - PEDIFIX, INC. (122271935)

Registrant - PEDIFIX, INC. (122271935)

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

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