FUNGISOLVE Tolnaftate Antifungal Cream

Manufacturer
Dannso Corp./d.b.a. Essential Products | GADAL Laboratories, Inc
Effective date
2016-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
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) can prevent recurrence of most athlete's foot relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.

Dosage and administration

adults and children 12 years and over wash the affected area and dry thoroughly apply a thin layer over affected area twice daily morning and night supervis 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.

Storage and handling

store between 20 to 25 C (68 to 77)F do not accept if safety seal is torn 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)

can prevent recurrence of most athlete's foot

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • children under 2 years of age unless directed by a doctor
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Stop use and ask a doctor if

OTC - STOP USE SECTION

too much irritation occurs or irratation gets worse

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes or mouth. If eye contacts occurs, rinse eyes thoroughtly with water.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily morning and night
  • supervis 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.

Other Information

STORAGE AND HANDLING SECTION

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

do not accept if safety seal is torn broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceteareth-6, cety stearyl alcohol, methylparaben, mineral oil, PEG-20 cetyl/stearyl ether, propylene glycol, propylparaben, purified water, sodium m-bisulfite, stearyl alcohol.

Questions?

OTC - QUESTIONS SECTION

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

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790292FUNGISOLVE 1 % Topical CreamPSN2
103951tolnaftate 1 % Topical CreamPSN2
1790292tolnaftate 10 MG/ML Topical Cream [Fungisolve]SBD2
103951tolnaftate 10 MG/ML Topical CreamSCD2
1790292Fungisolve 1 % Topical CreamSY2
103951tolnaftate 1 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70242-108-012020-01-31C16284748780-19d75b9cf-f371-f424-e053-dadaa90a57ceFUNGISOLVE Tolnaftate Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-108-01FUNGISOLVE TOLNAFTATE ANTIFUNGAL28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-108FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]2Legacy NDC, 1 package rows20160503_cc538c88-6887-4cb2-bd76-ec56cbd9b509.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-10870242-108-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
d4144fcc-20aa-446d-ad87-65104294be02cc538c88-6887-4cb2-bd76-ec56cbd9b5092016-04-30WarningsExact identifier
spl id: d4144fcc-20aa-446d-ad87-65104294be02
spl set id: cc538c88-6887-4cb2-bd76-ec56cbd9b509

Reported adverse events (FAERS/openFDA)#

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