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 23:59:00

Label at a glance#

ProductCLARUS Antifungal
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).  Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.

Dosage and administration

For treatment of athlete's foot and ringworm: 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 ...

Storage and handling

Store between 20 -25 C (68 -77 F) 0 0 0 0

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 (tinea pedis) and ringworm (tinea corporis).  Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.

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:

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

Other information:

STORAGE AND HANDLING SECTION

Store between 20 -25 C (68 -77 F) 0 0 0 0

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARUS ANTIFUNGAL CREAM   Tolnaftate 1%  MEDICAL STRENGTH ANTIFUNGAL CREAM IN A VEHICLE CONTAINING TEA TREE OIL AND UREA   CLINICAL THERAPEUTIC SOLUTIONS  NET WT.  1.5 oz (45g)  PRFOESSIONAL   Distributed by Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719  www.CTSRX.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clarus CreamClarus Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299059Clarus 1 % Topical CreamPSN6
103951tolnaftate 1 % Topical CreamPSN6
1299059tolnaftate 10 MG/ML Topical Cream [Clarus]SBD6
103951tolnaftate 10 MG/ML Topical CreamSCD6
1299059Clarus 1 % Topical CreamSY6
1299059Clarus 10 MG/ML Topical CreamSY6
103951tolnaftate 1 % Topical CreamSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-001-01CLARUS Antifungal45 g in 1 TUBECREAM456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-001CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231106_7e8897ff-67d1-4336-866e-cb76a36edddc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE702
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G2
UREAINACTIVE INGREDIENT8W8T17847W2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44577-00144577-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SUNFLOWER OIL3W1JG795YIIACT
LAURETH-7Z95S6G8201IACT
TEA TREE OILVIF565UC2GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
UREA8W8T17847WIACT
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 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
4 equally ranked IID candidates
UREAUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
UREAUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii+route
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 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 Solutions7e8897ff-67d1-4336-866e-cb76a36edddc2023-11-05WarningsExact identifier
ndc (package): 44577-001-01
ndc (product): 44577-001
ndc11 (package): 44577000101
spl id: 0973b73d-5dc0-0986-e063-6294a90a5917
spl set id: 7e8897ff-67d1-4336-866e-cb76a36edddc

Reported adverse events (FAERS/openFDA)#

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