FDA.reportPublic FDA data

EmoniNail Antifungal Solution

Manufacturer
GG Healthworks Inc.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:01

Label at a glance#

ProductEmoniNail Antifungal
Active ingredientUNDECYLENIC ACID
Label structure8 sections

Indications and uses

Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

Dosage and administration

Wash 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 athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes andsocks at least once daily. For athlete's foot and ringworm: use daily for 4 weeks. If c...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10.00%

Purpose

OTC - PURPOSE SECTION

Topical Antifungal

Uses

INDICATIONS & USAGE SECTION

Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

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.

Stop use and ask a doctor if,

OTC - STOP USE SECTION

  • If irritation occurs or if there is no improvement within 4 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.

When using this product,

OTC - WHEN USING SECTION

avoid contact with eyes.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash 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 athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes andsocks 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 not 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

Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.

Other information

SPL UNCLASSIFIED SECTION

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251008undecylenic acid 10 % Topical SolutionPSN2
1251008undecylenic acid 100 MG/ML Topical SolutionSCD2
1251008undecylenic acid 10 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76973-071-08EmoniNail Antifungal24 mL in 1 BOTTLE, DROPPERLIQUID242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76973-071EMONINAIL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [GG HEALTHWORKS INC.]2Current NDC, Legacy NDC, 1 package rows20231106_84ace47a-d3ae-4735-87b6-dbbf1c40cf54.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76973-07176973-071-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SUNFLOWER OIL3W1JG795YIIACT
CETYL ALCOHOL936JST6JCNIACT
POLYSORBATE 207T1F30V5YHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
EmoniNail AntifungalUNDECYLENIC ACIDGG Healthworks Inc.84ace47a-d3ae-4735-87b6-dbbf1c40cf542023-11-06WarningsExact identifier
ndc (package): 76973-071-08
ndc (product): 76973-071
ndc11 (package): 76973007108
spl id: 0975bb48-247e-e8bd-e063-6394a90ae8d9
spl set id: 84ace47a-d3ae-4735-87b6-dbbf1c40cf54

Reported adverse events (FAERS/openFDA)#

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