FDA.reportPublic FDA data

FUNGISOLVE TOLNAFTATE ANTIFUNGAL

Manufacturer
Dannso Corp./d.b.a. Essential Products | GADAL Laboratories, Inc
Effective date
2016-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:51

Label at a glance#

ProductFUNGISOLVE TOLNAFTATE ANTIFUNGAL
Active ingredientTOLNAFTATE
Label structure14 sections

Indications and uses

cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris) relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.

Dosage and administration

wash the affected area and dry thoroughtly apply a thin layer over the affected area twice daily morning and night supervice 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 and socks at least once a day. for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if the con...

Storage and handling

store between 20 to 25 C (68 to 77)F Tamper evident do not accept if safety seal is broken or missing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%


Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)

relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.

Warnings

WARNINGS SECTION

For external use only use only as directed

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes or mouth
  • use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athelete's foot and ringworm) or 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash the affected area and dry thoroughtly
  • apply a thin layer over the affected area twice daily morning and night
  • supervice 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 and socks at least once a day.
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if the condiotion persists longer, ask a doctor
  • this product is not effective on scalp or nails

Other Information

STORAGE AND HANDLING SECTION

store between 20 to 25 C (68 to 77)F

Tamper evident do not accept if safety seal is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylated hydroxyanisole, DMDM Hyantoin, Ethoxydiglycol, Eucaliptu oil, Glycerin, Methyl Sallicylate, Pepermint oil, Polyethylene Glycol, Propylen glycol.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 305 2618762 M-F 9AM to 4PM Eastern Time

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790294FUNGISOLVE 1 % Topical SolutionPSN1
313423tolnaftate 1 % Topical SolutionPSN1
1790294tolnaftate 10 MG/ML Topical Solution [Fungisolve]SBD1
313423tolnaftate 10 MG/ML Topical SolutionSCD1
1790294Fungisolve 1 % Topical SolutionSY1
313423tolnaftate 1 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70242-106-012020-01-31C16284748780-19d75b9d1-269d-f424-e053-dadaa90a57ceFUNGISOLVE Tolnaftate Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-106-01FUNGISOLVE TOLNAFTATE ANTIFUNGAL30 mL in 1 TUBE, WITH APPLICATORLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-106FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]1Legacy NDC, 1 package rows20160503_65927394-abb7-406f-ac5f-5fd85e80aada.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-10670242-106-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
DMDM HYDANTOINBYR0546TOWIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
PEPPERMINT OILAV092KU4JHIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
b87d7401-f831-4e29-8207-988ed17061c665927394-abb7-406f-ac5f-5fd85e80aada2016-04-30WarningsExact identifier
spl id: b87d7401-f831-4e29-8207-988ed17061c6
spl set id: 65927394-abb7-406f-ac5f-5fd85e80aada

Reported adverse events (FAERS/openFDA)#

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