FDA.reportPublic FDA data

Comfortzone Antifungal Liquid Solution

Manufacturer
Hudson Health LLC
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:11:16

Label at a glance#

ProductUndecylenic Acid
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Indications and uses

For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm). For relief of: discomfort which may accompany these conditions itching burning redness irritation scaling soreness

Dosage and administration

Read all warnings and directions. Use only as directed. clean the affected area and dry thoroughly apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between toeswear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athl...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

For relief of:

discomfort which may accompany these conditions
itching
burning
redness
irritation
scaling
soreness

Warnings

WARNINGS SECTION

For external use only.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a healthcare professional before use.

Do not use

OTC - DO NOT USE SECTION

on children 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Use only as directed

INSTRUCTIONS FOR USE SECTION

by a doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • there is no improvement within 4 weeks
  • irritation occurs

Keep out of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Read all warnings and directions. Use only as directed.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between toeswear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing. If freezing occurs warm to room temperature
  • keep tightly closed when not in use

Inactive ingredient

INACTIVE INGREDIENT SECTION

isopropyl palmitate

Questions?

OTC - QUESTIONS SECTION

Call 1-877-237-0194

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

comfortzone

maximum strength

anti-fungal liquid

undecylienic acid

eliminates fungus on fingers, toes & around nails

  • easy to apply applicator brush
  • dries quickly
  • non-oily, clear formula
  • no unpleasant odor

NET 1 FL. OZ (30mL)

AF LiquidAF LiquidAF Liquid 2AF Liquid 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72446-004-012023-01-31C16284748780-1f386c64a-2cd7-0266-e053-dadaa90a7c1aComfortzone Antifungal Liquid Solution

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
72446-00472446-004-01

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
ISOPROPYL PALMITATE8CRQ2TH63MIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
115cfc1d-8430-75b4-e063-6394a90a7a634b6a8f23-bc1b-4cc3-be84-b91ad0f5e60e2024-02-14WarningsExact identifier
spl id: 115cfc1d-8430-75b4-e063-6394a90a7a63
spl set id: 4b6a8f23-bc1b-4cc3-be84-b91ad0f5e60e

Reported adverse events (FAERS/openFDA)#

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