FDA.reportPublic FDA data

Fortinia

Manufacturer
The Podiatree Company | EMS Contract Packaging
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:04

Label at a glance#

ProductFortinia
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

• cures most athlete’s foot infections and ringworm infections • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

wash affected area and dry thoroughly apply a thin layer to the affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks if condition persists longer, consult your doctor this product is n...

Storage and handling

Store at controlled room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• cures most athlete’s foot infections and ringworm infections

• relieves itching, burning, cracking, scaling and discomfort which

accompany these conditions

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • 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

  • wash affected area and dry thoroughly
  • apply a thin layer to the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks
  • if condition persists longer, consult your doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature

Questions or Suggestions?

OTC - QUESTIONS SECTION

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Fragrance, Glycerin, L-Arginine, Olea Europaea (Olive) Fruit Oil, Panthenol, Persia Gratissima (Avocado) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Esters, Stearic Acid, Stearyl Alcohol, Sodium Hydroxymethylglycinate, Titanium Dioxide, Triethanolamine, Urea (20%), Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN4
309367clotrimazole 10 MG/ML Topical CreamSCD4
309367clotrimazole 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-314-80Fortinia80 g in 1 BOTTLE, PUMPCREAM804

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54633-31454633-314-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL L-ARGININEW6957UBY9ZIACT
OLIVE OIL6UYK2W1W1EIACT
PANTHENOLWV9CM0O67ZIACT
PETROLATUM4T6H12BN9UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TROLAMINE9O3K93S3TKIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
UREA8W8T17847WIACT
AVOCADO OIL6VNO72PFC1IACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIMETHICONE 1000MCU2324216IACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEU73D397055IACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
STEARIC ACID4ELV7Z65APIACT

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
FortiniaCLOTRIMAZOLEThe Podiatree Company60ba6f8a-8617-d4f6-e053-2991aa0a4a712026-01-08WarningsExact identifier
ndc (package): 54633-314-80
ndc (product): 54633-314
ndc11 (package): 54633031480
spl id: 47e362c2-c358-adbe-e063-6294a90a6043
spl set id: 60ba6f8a-8617-d4f6-e053-2991aa0a4a71

Reported adverse events (FAERS/openFDA)#

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