FDA.reportPublic FDA data

Formula 3

Manufacturer
The Tetra Corporation
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 01:10:49

Label at a glance#

ProductFormula 3
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

For effective treatment of most athlete's foot and ringworm. Relieves: Itching Soreness Scaling Burning Cracking Irritation Redness Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.

Dosage and administration

For treatment of athlete's foot and ringworm Clean the affected area and dry thoroughly. Apply a thin layer of the product 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 spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's...

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

For effective treatment of most athlete's foot and ringworm.

Relieves:

  • Itching
  • Soreness
  • Scaling
  • Burning
  • Cracking
  • Irritation
  • Redness

Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.


Warnings

WARNINGS SECTION

For external use only.

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

When using this productavoid contact with eyes.

Stop use and ask a doctor if

  • When using for athlete's foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • When using for the prevention of athlete's foot: If irritation occurs,discontinue use and consult a doctor.

If pregnant or breastfeedingask a health professional before use.



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

For treatment of athlete's foot and ringworm

  • Clean the affected area and dry thoroughly. Apply a thin layer of the product 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 spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor. This product is not effective on scalp or nail.

To prevent athlete's foot:

  • Clean the feet and dry thoroughly.
  • Apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • Supervise children in the use of this product.
  • Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Apricot Kernel Oil, Rice Bran Oil, Sesame Seed Oil, Safflower Oil, simmondsia chinensis, Vitamin E Acetate, Methyl Paraben, Propyl Paraben and Butyl Paraben.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN22
313423tolnaftate 10 MG/ML Topical SolutionSCD22
313423tolnaftate 1 % Topical SolutionSY22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49406-003-152025-08-18C16284748780-12cef2736-b4bf-d83d-e063-dadaa90ab31f0895274b-a09d-4264-a43f-852e44eb3163
49406-003-152025-01-30C16284748780-12cef2736-b4bf-d83d-e063-dadaa90ab31f0895274b-a09d-4264-a43f-852e44eb3163

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49406-003-15Formula 31 in 1 BOXSOLUTION122
49406-003-15Formula 315 mL in 1 BOTTLESOLUTION1522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49406-003-15ML - Milliliter49406-00361ba9617-b5f8-4f1f-9d2e-32b3fe2d2d9612016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV5
TOLNAFTATEACTIVE MOIETY06KB629TKV5
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L05
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV85
JOJOBA OILINACTIVE INGREDIENT724GKU717M5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH5
RICE BRAN OILINACTIVE INGREDIENTLZO6K1506A5
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS5
SESAME OILINACTIVE INGREDIENTQX10HYY4QV5

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
49406-00349406-003-15

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
APRICOT KERNEL OIL54JB35T06AIACT
RICE BRAN OILLZO6K1506AIACT
SESAME OILQX10HYY4QVIACT
SAFFLOWER OIL65UEH262ISIACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLPARABEN3QPI1U3FV8IACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii+dosage form
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+dosage form
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii+dosage form
14 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
2 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
4 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+route
14 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii+dosage form
14 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
4 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+dosage form
14 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii+dosage form
14 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii+route
14 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii+route
14 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
4 equally ranked IID candidates

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
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
ndc (package): 49406-003-15
ndc (product): 49406-003
ndc11 (package): 49406000315
spl id: 3ca9d5fc-af08-41f8-e063-6394a90aaaef
spl set id: 0895274b-a09d-4264-a43f-852e44eb3163

Reported adverse events (FAERS/openFDA)#

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