FDA.reportPublic FDA data

FungaBlend 10

Manufacturer
Happy Foot Shop, LLC
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:52:04

Label at a glance#

ProductFungaBlend 10
Active ingredientTOLNAFTATE
Label structure7 sections

Indications and uses

Proven clinically effective in the treatment of most athlete's foot ( Tinea pedis ) and ringworm ( Tinea corporis ) Helps prevent most athlete's foot with daily use For effective relief of itching, burning and cracking.

Dosage and administration

Wash affected area and dry thoroughly Apply a thin layer 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 the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use daily for 4 weeks; if condition persists longer, ask a doctor Prevent at...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate  1.0%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Proven clinically effective in the treatment of most athlete's foot ( Tinea pedis) and ringworm ( Tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking.

Warnings

WARNINGS SECTION

  • ​For external use only

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • irritation occurs
  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash affected area and dry thoroughly
  • Apply a thin layer 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 the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • Prevent athlete's foot, apply once or twice daily (morning and/or night)
  • This product is not effective on scalp or nails

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Ageratina sp. (snakeroot) extract, aloe barbadensis (aloe vera gel) juice, aqua (deionized water), butylene glycol, C13-14 isoparaffin, citrus grandis (grapefruit) fruit extract, citrus medica limonum (lemon) peel oil, ethylhexylglycerin, laureth-7, lavandula officinalis (lavender) oil, melaleuca alternifolia (australia tea tree) leaf oil, origanum vulgare (oregano) leaf oil, phenoxyethanol, polyacrylamide, polysorbate-20, prunus amygdalus dulcis (almond) oil, rosmarinus officinalis (rosemary) leaf extract, SD-alcohol 40B, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) butter, thymus vulgaris (thyme) extract, tocopheryl acetate (vitamin e), urea.

Other information

SPL UNCLASSIFIED SECTION

Store between 20 ​o​to 25 ​o​ C (68​ ​o ​​to 77 ​o​ F)

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69983-026FUNGABLEND 10 (TOLNAFTATE) LIQUID [HAPPY FOOT SHOP, LLC]6Legacy NDC20241018_02bec15c-beab-4748-86ad-7a2d76a2607e.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69983-02669983-026-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PUMMELOET1TN5W71XIACT
LEMON OILI9GRO824LLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LAURETH-7Z95S6G8201IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
OREGANO LEAF OIL7D0CGR40U1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ALMOND OIL66YXD4DKO9IACT
ROSEMARYIJ67X351P9IACT
ALCOHOL3K9958V90MIACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
THYMECW657OBU4NIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UREA8W8T17847WIACT
TOLNAFTATE06KB629TKVACTIB

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
48efb718-be5c-2d8d-e063-6294a90ac73302bec15c-beab-4748-86ad-7a2d76a2607e2026-01-21WarningsExact identifier
spl set id: 02bec15c-beab-4748-86ad-7a2d76a2607e

Reported adverse events (FAERS/openFDA)#

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