Premier Wart Remover Gel Pen

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALICYLIC ACID- wart remover gel pen gel 
Premier Brands of America, 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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Premier Wart Remover Gel Pen

Active Ingredient

Salicylic acid 17%w/w

Purpose

Wart remover

Use

  • for the removal of common and 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 the interruption of the footprint pattern

Warnings

For external use only.

Flammable

  • keep away from fire or flame

​Do not use

  • if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

  • on moles, birthmarks and warts with hair growing from them

  • on mucous membranes

  • on irritated, infected or reddened skin

  • on genital warts and warts on the face

​Ask doctor before use if you have:

  • diabetes
  • poor blood circulation

​When using this product

  • avoid contact with eyes
  • if product gets into the eyes, flush with water for 15 minutes
  • avoid inhaling vapors

​Stop use and consult a doctor if

discomfort persists

​Keep out of reach of children.

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

Directions

  • wash affected area
  • may soak wart in for 5 minutes
  • dry area thoroughly
  • remove cap from pen
  • twist and click pen until wart remover gel is dispense onto the tip of the applicator. Initial use will require several rotations for the gel to load
  • apply a small amount at a time with applicator to sufficiently cover each wart
  • let dry
  • repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
  • for storage ensure applicator is free of excess gel before placing the insert pin back into the tip

Other information

  • store between 59°F to 86°F (15°C to 30°C)
  • if gel hardens at tip of applicator, dispense product and remove blockage

​Inactive ingredients

camphor, castro oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropyl alcohol, nitrocellulose, polysorbate 80, SDA 3C ethyl alcohol

Questions?

Call 1-866-964-0939

​Principal Display Panel

Premier


Maximum Strength
WART

REMOVER

GEL PEN

Salicylic Acid 17%

  • Safely removes common & plantar warts
  • Convenient & easy-to-use
  • No-drip, gel formula

1 PREFILLED APPLICATOR PEN

NET WT 0.04 OZ (1.25g)

wart remover gel pen 1

wart remover gel pen 2

SALICYLIC ACID 
wart remover gel pen gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 56104-240
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.21 g  in 1.25 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYL ACETATE (UNII: 76845O8NMZ)  
HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PYROXYLIN (UNII: KYR8BR2X6O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 56104-240-041.25 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/202107/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B01/01/202107/16/2021
Labeler - Premier Brands of America, Inc. (117557458)

Revised: 7/2021