FDA.reportPublic FDA data

ETADERM Advanced Antifungal Support

Manufacturer
NUEPHASE LLC
Effective date
2024-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:14

Label at a glance#

ProductETADERM Advanced Antifungal Support
Active ingredientUNDECYLENIC ACID
Label structure7 sections

Indications and uses

For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm). For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For arthlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. I...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25.00%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

  • For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).
  • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections.

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch).

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For arthlete's foot: Pay special attention to spaces between the toes; wear 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 condition persists longer, consult a doctor.
  • This product is no effective on the scalp or nails.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Extract, Eugenia Caryophyllus (Clove) Bud Oil, Helianthus Annuus (Sunflower) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Menthol, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2677799undecylenic acid 25 % Topical CreamPSN1
2677799undecylenic acid 250 MG/ML Topical CreamSCD1
2677799undecylenic acid 25 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84180-471-00ETADERM Advanced Antifungal Support29 mL in 1 JARCREAM291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84180-471ETADERM ADVANCED ANTIFUNGAL SUPPORT (UNDECYLENIC ACID) CREAM [NUEPHASE LLC]1Current NDC, 1 package rows20240325_adb12a1c-ece9-4a59-a62c-89d212c57e6f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84180-47184180-471-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
CLOVE OIL578389D6D0IACT
SUNFLOWER OIL3W1JG795YIIACT
TEA TREE OILVIF565UC2GIACT
MENTHOLL7T10EIP3AIACT
OLIVE OIL6UYK2W1W1EIACT
ALMOND OIL66YXD4DKO9IACT
.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
ETADERM Advanced Antifungal SupportUNDECYLENIC ACIDNUEPHASE LLCadb12a1c-ece9-4a59-a62c-89d212c57e6f2024-03-13WarningsExact identifier
ndc (package): 84180-471-00
ndc (product): 84180-471
ndc11 (package): 84180047100
spl id: 13874210-91df-0642-e063-6294a90a7c12
spl set id: adb12a1c-ece9-4a59-a62c-89d212c57e6f

Reported adverse events (FAERS/openFDA)#

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