SPL v3
SPL
SPL Set ID 16685c1e-940f-e960-e063-6294a90aaff8
Route
TOPICAL
Published
Effective Date 2024-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.4 g)
Inactive Ingredients
Paraffin Petrolatum Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-19

Description

Salicylic Acid 40%

Purpose

Wart Remover


Medication Information

Purpose

Wart Remover

Description

Salicylic Acid 40%

Uses
  • for the removal of common plantar warts
  • the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface
  • the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For external use only.

Biopure.

Directions
  • wash affected area: may soak wart in warm water for 5 minutes
  • dry area thoroughly
  • peel off backing paper
  • adhere medicated patch directly over wart
  • repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks
Do Not Use

on irritated skin or on any area that is infected or reddened

on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes

if you have diabetes or poor blood circulation

Questions?

please call 1-718-975-2586

Active Ingredient

Salicylic Acid 40%

Other Information

store between 59º and 86°F (15º and 30ºC)

Inactive Ingredients

lanolin, paraffin, petrolatum

Stop Use and Ask A Doctor If

discomfort persists.


Structured Label Content

Uses
  • for the removal of common plantar warts
  • the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface
  • the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

Wart Remover

Warnings

For external use only.

Biopure. (biopure.)

Directions
  • wash affected area: may soak wart in warm water for 5 minutes
  • dry area thoroughly
  • peel off backing paper
  • adhere medicated patch directly over wart
  • repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks
Do Not Use (Do not use)

on irritated skin or on any area that is infected or reddened

on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes

if you have diabetes or poor blood circulation

Questions?

please call 1-718-975-2586

Active Ingredient (Active ingredient)

Salicylic Acid 40%

Other Information (Other information)

store between 59º and 86°F (15º and 30ºC)

Inactive Ingredients (Inactive ingredients)

lanolin, paraffin, petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

discomfort persists.


Advanced Ingredient Data


Raw Label Data

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