Salicylic Acid (Extra Thick Callus Removers) Patch [Premier Brands Of America Inc.] -

SALICYLIC ACID (EXTRA THICK CALLUS REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]
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NDC	56104-014-04
Set ID	60d96d3f-de4e-4c5e-b452-2715ce8b1e08
Category	HUMAN OTC DRUG LABEL
Packager	Premier Brands of America Inc.
Generic Name
Product Class
Product Number
Application Number	PART358F

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Active ingredient

Salicylic acid 40%
Purpose

Callus remover
Use
- for the removal of calluses
- relieves pain by removing calluses
Warnings
For external use only.
Do not use
- if you are a diabetic
- have poor blood circulation
- on irritated skin, or any area that is infected or reddened
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 right away.
Directions
- wash affected area and dry thoroughly
- if necessary, cut medicated patch to fit callus
- apply adhesive side down of medicated patch onto callus
- cover medicated patch with pad
- after 48 hours, remove medicated patch
- repeat 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 15°C to 30°C (59°F to 86°F)
Inactive ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol
Questions?

call 1-866-964-0939
Principal Display Panel
Premier

Extra Thick
Callus Removers
Salicylic acid
NEW!
- Medicated Callus removal treatment
- Protects against pressure & pain
4 Pads

4 Medicated Patches

INGREDIENTS AND APPEARANCE

SALICYLIC ACID
extra thick callus removers patch

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	40 mg in 4

Ingredient Name	Strength
Inactive Ingredients
POLYVINYL ALCOHOL (UNII: 532B59J990)
VINYL ACETATE (UNII: L9MK238N77)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56104-014-04	4 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358F	01/01/2013

Labeler - Premier Brands of America Inc. (117557458)

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Medic