comfortzone medicated callus removers

comfortzone medicated callus removers
SPL v4
SPL
SPL Set ID fee137cf-48c0-4b62-b3e4-59acd504f5c3
Route
topical
Published
Effective Date 2018-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (40 mg)
Inactive Ingredients
polyvinyl alcohol, unspecified vinyl acetate high density polyethylene

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-08-31

Purpose

Callus remover

Description

Salicylic acid 40%


Medication Information

Warnings

For external use only.

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

Callus remover

Directions
  • wash affected area and dry thoroughlyif 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

Description

Salicylic acid 40%

Principal Display Panel

comfortzone

medicated

callus remvoers

salicylic acid

  • effective callus removal treatment
  • protects against pressure & friction

12 pads/ 8 medicated patches

Questions?

call 1-877-237-0194

Section 50569-3

Stop use and ask a doctor if discomfort persists

Do Not Use
  • if you are a diabetic
  • have poor blood circulation
  • on irritated skin, on any area that is infected or reddened
Active Ingredient

Salicylic acid 40%

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

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

Callus remover

Directions
  • wash affected area and dry thoroughlyif 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 (Other information)

store between 15°C to 30°C (59°F to 86°F)

Inactive Ingredients (Inactive ingredients)

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Principal Display Panel

comfortzone

medicated

callus remvoers

salicylic acid

  • effective callus removal treatment
  • protects against pressure & friction

12 pads/ 8 medicated patches

Questions?

call 1-877-237-0194

Section 50569-3 (50569-3)

Stop use and ask a doctor if discomfort persists

Do Not Use (Do not use)
  • if you are a diabetic
  • have poor blood circulation
  • on irritated skin, on any area that is infected or reddened
Active Ingredient (Active ingredient)

Salicylic acid 40%

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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