FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Cardinal Health
Effective date
2019-12-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:56:20

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wash or soak the affected area, may soak wart in warm water for 5 minutes dry area thoroughly apply small amount of wart remover with applicator to sufficiently cover each wart let dry and 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

Use

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 or flame
  • cap bottle tightly and store at room temperature away heat

Do not use

OTC - DO NOT USE SECTION

  • if you are a diabetic or have poor blood circulation, except under the supervision of a doctor or podiatrist
  • on irritated, infected or reddened skin
  • on genital warts and warts on the face
  • on moles, birthmarks and warts with hair growing from them
  • on mucous membranes

When using this product

OTC - WHEN USING SECTION

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

​Stop use and ask a doctor if discomforts persists.

OTC - STOP USE SECTION

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.

​Directions

DOSAGE & ADMINISTRATION SECTION

  • wash or soak the affected area, may soak wart in warm water for 5 minutes
  • dry area thoroughly
  • apply small amount of wart remover with applicator to sufficiently cover each wart
  • let dry and repeat this procedure once or twice daily as needed until wart is removed for up to 12 weeks

​Other information

OTHER SAFETY INFORMATION

store between 20°C to 30°C (68°F to 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, castor oil, ethanol, ethyl ether, nitrocellulose

​Questions?

OTC - QUESTIONS SECTION

Call 1-800-200-6313

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

Liquid Wart Remover

with Salicylic Acid

  • Removes Common and Plantar Warts
  • Removes Common and Plantar Warts, Safely and Easily

Net 0.31 FL OZ (9mL)

​

Leader Liquid Wart Rem box-53-012LD.jpgLeader Liquid Wart Rem box-53-012LD.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ3
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q9413
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G3
PYROXYLININACTIVE INGREDIENTKYR8BR2X6O3

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49781-11549781-115-15, 49781-115-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYROXYLINKYR8BR2X6OIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CASTOR OILD5340Y2I9GIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates

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
c6ed7f8b-5aa1-eb84-e053-2a95a90aef8c6ebc16ca-1dcc-4b89-a13c-3f867ea92e7b2021-07-12WarningsExact identifier
spl set id: 6ebc16ca-1dcc-4b89-a13c-3f867ea92e7b

Reported adverse events (FAERS/openFDA)#

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