Salicylic Acid
Premier Solutions Clear Medicated Wart Remover
Approved
Approval ID
400ea33f-9080-ff8e-e063-6294a90a6da0
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 30, 2025
Manufacturers
FDA
Premier Brands of America Inc.
DUNS: 063849780
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Medicated Wart Removers
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code56104-910
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Medicated Wart Removers
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification
INGREDIENTS (3)
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
VINYL ACETATEInactive
Code: L9MK238N77
Classification: IACT
SALICYLIC ACIDActive
Quantity: 400 mg in 1 g
Code: O414PZ4LPZ
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/10/2019
Principal Display Panel
Premier Solutions
Medicated
Clear Wart
Remover Strips
SALICYLIC ACID 40%
MAXIMUM STRENGTH
- Safely removes common & plantar warts
- Conceals & protects
- Medicated disc, no-mess application
18 MEDICATED DISCS | 14 CLEAR STRIPS
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/10/2019
Use
- For the removal of warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface.
WARNINGS SECTION
LOINC: 34071-1Updated: 9/10/2019
Warnings
For external use only.
Do not use
- if you are a diabetic
- if you have poor blood circulation
- on irritated skin or any area that is infected or reddened
- on genital warts or warts on the face
- on moles, birthmarks and warts with hair growing from them
- on mucous membranes such as nose, anus, genitals and lips
Stop use and ask a doctor if
discomfort persists
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/10/2019
Directions
- wash affected area.
- may soak corn in warm water for 5 minutes.
- dry area thoroughly
- if necessary, cut medicated disc to fit the wart.
- carefully apply the medicated with sticky side onto the wart.
- cover the medicated disc with the center of the bandage strip.
- repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks.
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 9/10/2019
Other information
store between 59° and 86°F (15° and 30°C)
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 9/10/2019
Inactive ingredients
acrylic adhesive, polyethylene foam.
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 9/10/2019
Questions?
Call 1-866-964-0939
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 9/10/2019
Active ingredient
Salicylic acid 40% w/w
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 9/10/2019
Purpose
Wart remover