FDA.reportPublic FDA data

Freezone

Manufacturer
Medtech Products Inc.
Effective date
2017-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:11

Label at a glance#

ProductFreezone
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

Wash affected area. You may soak callus or corn in warm water for 5 minutes. Dry area thoroughly Apply one drop at a time to cover each corn or callus. Let dry. Repeat procedure once or twice daily as needed for up to 14 days (until corn or callus is removed).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 17.6% in a flexible collodion base

Purpose

OTC - PURPOSE SECTION

Corn/Callus Remover

Use

INDICATIONS & USAGE SECTION

For the removal of corns and calluses

Warnings

WARNINGS SECTION

For external use only.

  • Extremely flammable. Keep away from fire or flame.
  • Cap bottle tightly and store at room temperature away from heat.

Do not use this product

OTC - DO NOT USE SECTION

  • on irritated skin
  • on any area that is infected or reddened
  • if you are diabetic
  • if you have poor blood circulation

Stop use and ask a doctor if

OTC - STOP USE SECTION

discomfort persists

When using this product

OTC - WHEN USING SECTION

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

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash affected area.
  • You may soak callus or corn in warm water for 5 minutes.
  • Dry area thoroughly
  • Apply one drop at a time to cover each corn or callus.
  • Let dry.
  • Repeat procedure once or twice daily as needed for up to 14 days (until corn or callus is removed).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol 27%, ether 57%

Questions?

OTC - QUESTIONS SECTION

1-800-443-4908

Freezone® Liquid Corn & Callus Remover, 0.3 fl oz (9 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freezone Liquid Corn and Callus Remover CartonFreezone Liquid Corn and Callus Remover Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-104-032023-03-03C16284748780-1f386c649-9cd1-0266-e053-dadaa90a7c1aFreezone® Liquid Corn & Callus Remover
63029-104-032023-01-30C16284748780-1f386c649-9cd1-0266-e053-dadaa90a7c1aFreezone® Liquid Corn & Callus Remover

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-104-03ML - Milliliter63029-104db220512-0dea-436e-a1dd-c49ed7948b7512022-06-06

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
63029-10463029-104-03

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
ALCOHOL3K9958V90MIACT
ETHER0F5N573A2YIACT

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
915b7181-c69a-4bc5-8716-ac511129846ff55b64b3-d87d-4c96-9a73-96325059e6b82023-03-03WarningsExact identifier
spl set id: f55b64b3-d87d-4c96-9a73-96325059e6b8

Reported adverse events (FAERS/openFDA)#

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