FDA.reportPublic FDA data

BLUEDOT One-Step Corn Remover Strips

Manufacturer
CREST MEDICAL LIMITED | KRE EOOD
Effective date
2024-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:54:59

Label at a glance#

ProductBLUEDOT One-Step Corn Remover Strips
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

• For the removal of corns and calluses • Relieves pain by removing corns and calluses • Adhesive bandage holds the medicated pad in position

Dosage and administration

• Wash affected area and dry thoroughly • Apply medicated bandage after 48 hours, remove medicated bandage • Repeat procedure every 48 hours as needed for up to 14 days (until corn is removed) • May soak corn in warm water for 5 minutes to assist in removal

Storage and handling

Store between 0° to 40°C (32° to 104°F)

Label contents#

Full prescribing information#

Active ingredient (in each dosage unit)

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 40% in a plaster vehicle

Purposes

OTC - PURPOSE SECTION

Corn and calluses removal

Uses

INDICATIONS & USAGE SECTION

• For the removal of corns and calluses
• Relieves pain by removing corns and calluses
• Adhesive bandage holds the medicated pad in position

Warnings

WARNINGS SECTION

For external use only

Do not use
• If you are a diabetic
• If you have poor blood circulation
• On irritated skin or any area that is infected or reddened

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 and dry thoroughly
• Apply medicated bandage after 48 hours, remove medicated bandage
• Repeat procedure every 48 hours as needed for up to 14 days (until corn is removed)
• May soak corn in warm water for 5 minutes to assist in removal

Other information

STORAGE AND HANDLING SECTION

Store between 0° to 40°C (32° to 104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylic adhesive, Titanium dioxide, Ferric hydroxide

Questions?

OTC - QUESTIONS SECTION

1-800-723-2465

SPL UNCLASSIFIED SECTION

• Maximum Strength

• Medicated Pad

• Water Resistant

• Stays in place

DISTRIBUTED BY:
Crest Medical Ltd.
3 Chesford Grange,
Warrington, Cheshire.
WA1 4RQ. UK.

www.crestmedical.co.uk
MADE IN BULGARIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OneStepCR-1OneStepCR-1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84713-101BLUEDOT ONE-STEP CORN REMOVER STRIPS (SALICYLIC ACID) PLASTER [CREST MEDICAL LIMITED]1Unmatched20240915_7bdc293e-fa25-4f66-bf81-998fe4839ee4.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84713-10184713-101-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC HYDROXIDE2UA751211NIACT

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
0d344303-5f9d-4dde-94f9-4a4a7d3d20cf7bdc293e-fa25-4f66-bf81-998fe4839ee42026-01-14WarningsExact identifier
spl set id: 7bdc293e-fa25-4f66-bf81-998fe4839ee4

Reported adverse events (FAERS/openFDA)#

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