FDA.reportPublic FDA data

Sally Hansen

Manufacturer
Coty US LLC | Kolmar Laboratories Inc.
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:44:19

Label at a glance#

ProductSally Hansen No More Fungus
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Indications and uses

cures most ringworm (tinea corporis) and athlete's foot (tinea pedis). Soothes: itching scaling cracking burning redness soreness irritation discomfort itchy, scaling skin between the toes itching, burning feet

Dosage and administration

Use daily for 4 weeks. This product is not effective on the scalp or nails. 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, veniltated shoes change shoes and socks at least once...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).

Soothes:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort
  • itchy, scaling skin between the toes
  • itching, burning feet

Warnings

WARNINGS SECTION

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes.

Stop use and ask a doctor if:

  • irritation occurs
  • there is not 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Use daily for 4 weeks. This product is not effective on the scalp or nails.

  • 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, veniltated shoes
  • change shoes and socks at least once daily

Other Information

OTHER SAFETY INFORMATION

  • do not use if the printed seal is broken or missing prior to opening
  • keep away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

proplylene glycol dicaprylate/dicaprate, parfum/fragrance, limonene, linalool

Questions or comments?

OTC - QUESTIONS SECTION

To report a serious adverse event and for informaiton or comments on this product call us at 1-800-953-5080

9:00AM-5:00PM EST or visit www.sallyhansen.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrimaryPrimary

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN5
998329undecylenic acid 250 MG/ML Topical SolutionSCD5
998329undecylenic acid 25 % Topical SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66184-151-022023-01-30C16284748780-1f386c64a-10cc-0266-e053-dadaa90a7c1a9f12bfcb-c0f5-4113-996c-917976c01349

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66184-151-01Sally HansenNo More Fungus39 mL in 1 BOTTLE, DROPPERLIQUID395
66184-151-02Sally HansenNo More Fungus1 in 1 BOXLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66184-151SALLY HANSEN NO MORE FUNGUS (UNDECYLENIC ACID) LIQUID [COTY US LLC]5Legacy NDC, 2 package rows20211020_9f12bfcb-c0f5-4113-996c-917976c01349.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N1
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1W1
LINALOOL, (+)-INACTIVE INGREDIENTF4VNO44C091
PROPYLENE GLYCOL DICAPRYLATEINACTIVE INGREDIENT581437HWX21

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66184-15166184-151-01, 66184-151-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL DICAPRYLATE581437HWX2IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+)-F4VNO44C09IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WGEL / TOPICAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOL DICAPRYLATEPROPYLENE GLYCOL DICAPRYLATE581437HWX2CREAM / TOPICAL1200 mgExact identifier — unii candidate
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WLOTION / TOPICAL10 %v/vExact identifier — unii candidate
3 equally ranked IID candidates

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
ceb4dc33-4481-6213-e053-2a95a90a9b1e9f12bfcb-c0f5-4113-996c-917976c013492021-10-19WarningsExact identifier
spl id: ceb4dc33-4481-6213-e053-2a95a90a9b1e
spl set id: 9f12bfcb-c0f5-4113-996c-917976c01349

Reported adverse events (FAERS/openFDA)#

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