FDA.reportPublic FDA data

DuoFilm Wart Remover

Manufacturer
Bayer HealthCare LLC
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:55:45

Label at a glance#

ProductDuoFilm Wart Remover
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

for removal of common and plantar warts common warts can be easily recognized by the rough cauliflower-like appearance of the surface plantar warts can be recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern

Dosage and administration

wash affected area may soak wart in warm water for 5 minutes dry thoroughly apply one drop at a time with applicator to sufficiently cover each wart let dry self-adhesive cover-up discs may be used to conceal wart repeat procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Storage and handling

store between 20° to 25°C (68° to 77°F) keep tightly closed

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 removal of common and plantar warts
  • common warts can be easily recognized by the rough cauliflower-like appearance of the surface
  • plantar warts can be 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 Keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

  • if you have diabetes
  • if you have poor blood circulation
  • on irritated skin or 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

When using this product

OTC - WHEN USING SECTION

  • if product gets in eyes, flush with water for 15 minutes
  • do not inhale vapors
  • cap bottle tightly when not in use and store at room temperature away from heat

OTC - STOP USE SECTION

Stop use and ask a doctor if discomfort lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area
  • may soak wart in warm water for 5 minutes
  • dry thoroughly
  • apply one drop at a time with applicator to sufficiently cover each wart
  • let dry
  • self-adhesive cover-up discs may be used to conceal wart
  • repeat procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

castor oil, ethyl lactate, flexible collodion, polybutene. (Contains alcohol 18% v/v and ether 53% v/v from flexible collodion).

Questions?

OTC - QUESTIONS SECTION

866-360-3226

PRINCIPAL DISPLAY PANEL - 9.8 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIQUID

DuoFilm ®

SALICYLIC ACID WART REMOVER

  • Safe and reliable removal of

    common and plantar warts
  • Cover-up discs protect warts

    as they heal

1/3 FL OZ (9.8 mL)

20 cover-up discs

package labelpackage label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0635-2ML - Milliliter11523-0635917e9690-a759-406e-8f82-adfbd2924bb212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ3
Salicylic AcidACTIVE MOIETYO414PZ4LPZ3
alcoholINACTIVE INGREDIENT3K9958V90M3
castor oilINACTIVE INGREDIENTD5340Y2I9G3
etherINACTIVE INGREDIENT0F5N573A2Y3
ethyl lactateINACTIVE INGREDIENTF3P750VW8I3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-063511523-0635-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
ETHYL LACTATEF3P750VW8IIACT
ALCOHOL3K9958V90MIACT
ETHER0F5N573A2YIACT
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 2 · 75 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GTABLET / ORAL17 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
98e6fc5f-dc67-4a07-e053-2995a90a0d06741f5e19-2bea-4adf-9ae2-204bff1275362019-12-04WarningsExact identifier
spl id: 98e6fc5f-dc67-4a07-e053-2995a90a0d06
spl set id: 741f5e19-2bea-4adf-9ae2-204bff127536

Reported adverse events (FAERS/openFDA)#

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