FDA.reportPublic FDA data

Wart Remover Gel Tube

Manufacturer
Foodhold USA
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:41:04

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern.

Dosage and administration

after washing affected area, soak wart in for 5 minutes in comfortably warm water dry area thoroughly apply one drop of gel at a time to sufficiently cover each wart let dry repeat this procedure once or twice daily (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 of the surface.
  • Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern.

Warnings

WARNINGS SECTION

For external use only.

Flammable

SAFE HANDLING WARNING SECTION

keep away from fire and flame

Do not use

OTC - DO NOT USE SECTION

  • on moles, birth marks and warts with hair growing from them
  • on mucous membranes such as nose, anus, genitals and lips
  • on irritated, infected or reddened skin
  • on genital warts and warts on the face
  • if you are diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

When using this product

OTC - WHEN USING SECTION

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

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 right away.

if discomfort persists

OTC - ASK DOCTOR SECTION

see your doctor or podiatrist.

Directions

DOSAGE & ADMINISTRATION SECTION

  • after washing affected area, soak wart in for 5 minutes in comfortably warm water
  • dry area thoroughly
  • apply one drop of gel at a time to sufficiently cover each wart
  • let dry
  • repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

MAXIMUM STRENGTH

WART REMVOER GEL

SALICYLIC ACID

SAFELY REMVOES COMMON AND PLANTAR WARTS

CONVENTIENT & EASY

NO DRIP FORMULA

NET WT 0.25 OZ (7 g)

Care One_Gel Wart Remover_53-039CO-01.jpgCare One_Gel Wart Remover_53-039CO-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-567-252024-01-17C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252024-01-17C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252022-01-28C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252022-01-28C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252020-10-14C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252020-10-14C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252020-01-31C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube
41520-567-252020-01-31C16284748780-19d75b9d1-1d5b-f424-e053-dadaa90a57ceWart Remover Gel Tube

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-567-25Salicylic Acid7 g in 1 TUBEGEL79

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-56741520-567-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941IACT
ALCOHOL3K9958V90MIACT
ETHYL ACETATE76845O8NMZIACT
HYPOPHOSPHOROUS ACID8B1RL9B4ZJIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
POLYSORBATE 806OZP39ZG8HIACT
PYROXYLINKYR8BR2X6OIACT
CASTOR OILD5340Y2I9GIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-11-07full-release2026-06-01 00:36:26

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
Salicylic AcidWART REMOVER GELFoodhold USAfbcf110c-a891-4207-aeb8-a878baf223e02025-10-27WarningsExact identifier
ndc (package): 41520-567-25
ndc (product): 41520-567
ndc11 (package): 41520056725
spl id: 422aa9d5-f08a-2b69-e063-6294a90a4b97
spl set id: fbcf110c-a891-4207-aeb8-a878baf223e0

Reported adverse events (FAERS/openFDA)#

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