FDA.reportPublic FDA data

Compound W Total Care Wart and Skin Kit

Manufacturer
HK Kolmar Canada, Inc
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:23

Label at a glance#

ProductCompound W Total Care Wart and Skin Kit
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

for the removal of common and plantar warts the common wart is easily recognized by the rough “cauliflower-like” appearance on 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

Dosage and administration

wash affected area may soak wart in warm water for 5 minutes dry area thoroughly by squeezing tube gently, apply one drop at a time 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 17% w/w

Purpose

OTC - PURPOSE SECTION

Wart remover

Uses

INDICATIONS & USAGE SECTION

  • for the removal of common and plantar warts
  • the common wart is easily recognized by the rough “cauliflower-like” appearance on 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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire and flame.

Do not use

OTC - DO NOT USE SECTION

  • 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.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.
  • avoid inhaling vapors
  • cap tightly and store at room temperature away from heat

Stop use and ask a doctor if

OTC - STOP USE SECTION

discomfort persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area
  • may soak wart in warm water for 5 minutes
  • dry area thoroughly
  • by squeezing tube gently, apply one drop at a time 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

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • avoid excessive heat 37°C (99°F)
  • skin discoloration may accur during or after use
  • wipe the tip of the tube with a paper towel between uses

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, camphor, castor oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropanol, nitrocellulose, polysorbate 80, water

Questions?

OTC - QUESTIONS SECTION

1-800-443-4908  CompoundW.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
210140Compound W 17 % Topical GelPSN2
312880salicylic acid 17 % Topical GelPSN2
210140salicylic acid 0.17 MG/MG Topical Gel [Compound W brand of salicylic acid]SBD2
312880salicylic acid 0.17 MG/MG Topical GelSCD2
210140Compound W brand of salicylic acid 0.17 MG/MG Topical GelSY2
210140Compound W brand of salicylic acid 17 % Topical GelSY2
312880salicylic acid 17 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49354-003-00Compound W Total Care Wart and Skin Kit7 g in 1 TUBEGEL7 g170 mg in 1g2
49354-003-00Compound W Total Care Wart and Skin Kit1 in 1 CARTONGEL170 mg in 1g2
49354-130-00Compound W Total Care Wart and Skin Kit1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49354-003COMPOUND W TOTAL CARE WART AND SKIN KIT (SALICYLIC ACID) KIT [HK KOLMAR CANADA, INC]2Unmatched20231030_def46762-990a-48b0-b702-15ece1dc541f.zip
49354-130COMPOUND W TOTAL CARE WART AND SKIN KIT (SALICYLIC ACID) KIT [HK KOLMAR CANADA, INC]2Current NDC, Legacy NDC, 3 package rows20231030_def46762-990a-48b0-b702-15ece1dc541f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49354-13049354-130-00
49354-00349354-003-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CASTOR OILD5340Y2I9GIACT
ETHYL ACETATE76845O8NMZIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPOPHOSPHOROUS ACID8B1RL9B4ZJIACT
ISOPROPYL ALCOHOLND2M416302IACT
PYROXYLINKYR8BR2X6OIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Compound W Total Care Wart and Skin KitSALICYLIC ACIDHK Kolmar Canada, Incdef46762-990a-48b0-b702-15ece1dc541f2023-10-27WarningsExact identifier
ndc (package): 49354-130-00
ndc (package): 49354-003-00
ndc (product): 49354-130
ndc11 (package): 49354000300
ndc11 (package): 49354013000
spl id: 08bf29ff-1c69-1547-e063-6294a90ac7ee
spl set id: def46762-990a-48b0-b702-15ece1dc541f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.