FDA.reportPublic FDA data

CLARUS Antifungal

Manufacturer
Clinical Therapeutic Solutions | Pure Source, LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:58:55

Label at a glance#

ProductCLARUS Antifungal
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

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

Dosage and administration

For treatment of athlete's foot and ringworm: If condition persists longer, consult a physician. This product is not effective on scalp or nail infections. To prevent athlete's foot: 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 physician. Supervise children in the use of this product. For athlete's foot: Pay spe...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate   1 %

Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses:

INDICATIONS & USAGE SECTION

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

Prevents the reoccurrence of most athlete's foot with daily use.

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

Warnings

WARNINGS SECTION

For external use only.  Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a physician.

Stop use and ask physician if:

OTC - STOP USE SECTION

  • 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 physician.
  • When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

For treatment of athlete's foot and ringworm:

If condition persists longer, consult a physician. This product is not effective on scalp or nail infections.

To prevent athlete's foot:

  • 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 physician.
  • 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.
  • 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 shoes, and change shoes and socks at least once daily.

Questions or Comments?

OTC - QUESTIONS SECTION

Please visit  www.CTSRX.com

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Amygdalus Dulcis (Sweet Almond) Oil, BHT, Helianthus Annuus (Sunflower) Seed Oil, Mentha Piperita (Peppermint) Oil, Sesamum Indicum (Sesame) Seed Oil, Tocopheryl Acetate (Vitamin E).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARUS ANTIFUNGAL SOLUTION Tolnaftate 1%  MEDICAL STRENGTH ANTIFUNGAL SOLUTION CLINICAL THERAPEUTIC SOLUTIONS  PO Box 1257, Wall, NJ 07719   0.5 FL OZ (15 mL)

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clarus SolutionClarus Solution

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299066CLARUS 1 % Topical SolutionPSN6
313423tolnaftate 1 % Topical SolutionPSN6
1299066tolnaftate 10 MG/ML Topical Solution [Clarus]SBD6
313423tolnaftate 10 MG/ML Topical SolutionSCD6
1299066Clarus 1 % Topical SolutionSY6
1299066Clarus 10 MG/ML Topical SolutionSY6
313423tolnaftate 1 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-002-01CLARUS Antifungal15 mL in 1 BOTTLESOLUTION156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-002CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231106_308a91d1-3511-4e2d-a62f-a31d77d70e06.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH2
SESAME OILINACTIVE INGREDIENTQX10HYY4QV2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44577-00244577-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALMOND OIL66YXD4DKO9IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SUNFLOWER OIL3W1JG795YIIACT
PEPPERMINT OILAV092KU4JHIACT
SESAME OILQX10HYY4QVIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 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
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
4 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii+dosage form
8 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
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii+dosage form
8 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 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
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii+dosage form
8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 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
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions308a91d1-3511-4e2d-a62f-a31d77d70e062023-11-05WarningsExact identifier
ndc (package): 44577-002-01
ndc (product): 44577-002
ndc11 (package): 44577000201
spl id: 09740b13-55d0-2604-e063-6294a90a158c
spl set id: 308a91d1-3511-4e2d-a62f-a31d77d70e06

Reported adverse events (FAERS/openFDA)#

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