FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Foodhold USA
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:40:33

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wash affected area: may soak wart in warm water for 5 minutes dry area thoroughly remove bandage strips by peeling backing off at slit adhere medicated patch directly over wart repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 40%w/w

​Purpose

OTC - PURPOSE SECTION

Wart remover

​Use

INDICATIONS & USAGE SECTION

  • for the removal of common warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface.

​Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • 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 such as nose, anus, genitals a

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • diabetes
  • poor blood circulation

Stop use and ask a doctor if

OTC - STOP USE SECTION

discomforts 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 right away.

​Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area: may soak wart in warm water for 5 minutes
  • dry area thoroughly
  • remove bandage strips by peeling backing off at slit
  • adhere medicated patch directly over wart
  • repeat this procedure every 48 hours as needed (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

acrylic adhesive, polyethylene foam

​Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne

Maximum Strength

One-Step Wart Remover

Salicylic Acid

  • Effective Wart Removal Treatment
  • Medicted Strips Cover and Remove Warts
  • One-Step Application Without the Mess of Liquids
  • Seals and Protects

14 MEDICATED STRIPS

Care One_One-Step Wart Removers_53-017CO.jpgCare One_One-Step Wart Removers_53-017CO.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-164-142023-01-12C16284748780-1c7ccaba7-0ecd-fd44-e053-dadaa90aa01bCareOne One Step Wart Remover
41520-164-142021-07-23C16284748780-1c7ccaba7-0ecd-fd44-e053-dadaa90aa01bCareOne One Step Wart Remover

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-16441520-164-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
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
0a24908f-0fd7-ee04-e063-6394a90a26a42f494f28-e5e6-4dd3-bf8f-8f643b7ed5522023-11-14WarningsExact identifier
spl set id: 2f494f28-e5e6-4dd3-bf8f-8f643b7ed552

Reported adverse events (FAERS/openFDA)#

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