FDA.reportPublic FDA data

Dermaced Maximum Strength Anti-Fungal

Manufacturer
Dermaced, LLC
Effective date
2017-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:15:15

Label at a glance#

ProductDermaced Maximum Strength Anti-Fungal
Active ingredientUNDECYLENIC ACID
Label structure6 sections

Indications and uses

For cure of most: • ringworm (tinea corporis) • athletes foot (tinea pedis). For the relief of: • itching • scaling • creaking • burning • redness • soreness • irritation and discomforts which may accompany these conditions.

Dosage and administration

• Clean and dry affected area with soap and water and dry thoroughly. • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. • For athletes foot and ringworm. If condition persists for longer, consult a physician, • Intended for use by normally ...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose:

OTC - PURPOSE SECTION

Anti-fungal

Uses:

INDICATIONS & USAGE SECTION

For cure of most: • ringworm (tinea corporis) • athletes foot (tinea pedis). For the relief of: • itching • scaling • creaking • burning • redness • soreness • irritation and discomforts which may accompany these conditions.

Warnings:

WARNINGS SECTION

For external use only.

Ask a doctor before use 

OTC - ASK DOCTOR SECTION

  • on children under two-years of age.

DO NOT USE

OTC - DO NOT USE SECTION

on diaper rash. When using this product avoid contact with eyes.

Stop use and ask a doctor If

OTC - STOP USE SECTION

  • irritation occurs • there is no improvement within four weeks.

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

• Clean and dry affected area with soap and water and dry thoroughly. • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. • For athletes foot and ringworm. If condition persists for longer, consult a physician, • Intended for use by normally healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician. • This product is not meant to be applied directly to the scalp or nails.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Cymbopogon Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71515-83271515-832-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
07223f5c-7263-9174-e063-6394a90a632f531ff07b-f26b-293d-e054-00144ff8d46c2023-10-07WarningsExact identifier
spl set id: 531ff07b-f26b-293d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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