Sisquoc HC (as PLD) - FUNGINIX AF ATHLETE'S FOOT CREAM (71229-103)

Manufacturer
The Sisquoc Healthcare Corporation
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:56:07

Label at a glance#

ProductFUNGINIX AF
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

ANTI-FUNGAL TREATMENT

Dosage and administration

For the cure of all forms of athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.  Wash affected area and dry thoroughly. Apply a layer of FUNGINIX AF over the affected area twice daily (morning and night). Allow the cream to dry for at least 3 minutes before covering the affected area with clothing.  Wa...

Storage and handling

Store between 20°c to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TOLNAFTATE 1%

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

USES

INDICATIONS & USAGE SECTION

  • ANTI-FUNGAL TREATMENT

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE THE EYES VERY THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OCCURS OR THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • For the cure of all forms of athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions. 
  • Wash affected area and dry thoroughly. Apply a layer of FUNGINIX AF over the affected area twice daily (morning and night). Allow the cream to dry for at least 3 minutes before covering the affected area with clothing. 
  • Wash hands after each application to prevent the chance of the infection spreading to other parts of the skin. 
  • Most athlete’s foot infections will require at least 2 weeks of continuous daily treatment before the infection is completely eliminated.
  • Proper use of FUNGINIX AF should eliminate all types of athlete’s foot infections. If the condition persists longer, contact a physician or medical professional.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Oleth-10 Phosphate, Triethanolamine, Polysorbate 20, Acrylates Copolymer, Glycerin,
Propylene Glycol, Uva Ursi (Bearberry) Extract, Beta-Glucan, Propolis Extract, Aloe Barbadensis Juice, Tocopheryl Acetate (Vitamin E), Camphor, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Jasminum Officinale (Jasmine) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Theobroma Cacao (Cocoa) Seed Butter, Rosa Canina (Rose Hip) Flower Oil, Cetyl  Hydroxyethylcellulose, Ethylhexylglycerin, Phenoxyethanol

STORAGE AND HANDLING SECTION

Store between 20°c to 25°C (68° to 77°F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Funginix AF LabelFunginix AF Label

Funginix AF InsertFunginix AF Insert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN7
103951tolnaftate 10 MG/ML Topical CreamSCD7
103951tolnaftate 1 % Topical CreamSY7

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71229-103-11FUNGINIX AF28 g in 1 TUBECREAM287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71229-103FUNGINIX AF (TOLNAFTATE) CREAM [THE SISQUOC HEALTHCARE CORPORATION]7Current NDC, Legacy NDC, 1 package rows20250227_f6cf5315-6678-486c-85b2-d4b3f748600e.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71229-10371229-103-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 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
FUNGINIX AFTOLNAFTATEThe Sisquoc Healthcare Corporationf6cf5315-6678-486c-85b2-d4b3f748600e2025-02-25WarningsExact identifier
ndc (package): 71229-103-11
ndc (product): 71229-103
ndc11 (package): 71229010311
spl id: 2f007d49-0eeb-511e-e063-6394a90ae3f8
spl set id: f6cf5315-6678-486c-85b2-d4b3f748600e

Reported adverse events (FAERS/openFDA)#

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