FDA.reportPublic FDA data

Dr CANUSO fungal nail eraser

Manufacturer
Renu Laboratories, LLC
Effective date
2025-05-13
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:00:54

Label at a glance#

ProductDr CANUSO fungal nail eraser
Active ingredientTOLNAFTATE
Label structure12 sections

Indications and uses

Helps cure most fungal nail and skin infections including Fungus (Tinea Pedis) Effectively relieves cracking, scaling and soreness accompanying the above conditon

Dosage and administration

Trim nails and file the surface of nails using an emory board Apply a thin layer of the product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around the toenails. Allow solution to soak into nail or skin Application to adjacent nails is recommended to prevent the spread of infection Keep affected areas clean and dry throughout the ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

Purpose

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Helps cure most fungal nail and skin infections including Fungus (Tinea Pedis)
  • Effectively relieves cracking, scaling and soreness accompanying the above conditon

WARNINGS SECTION

Warnings

For external use only

  • Do not use on children under 2 years of age unless directed by a doctor
  • Avoid contact with eyes, ears or mouth
  • Stop use and ask a physician if rash or irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health Professional before use

Directions

OTC - WHEN USING SECTION

  • Trim nails and file the surface of nails using an emory board
  • Apply a thin layer of the product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around the toenails.
  • Allow solution to soak into nail or skin
  • Application to adjacent nails is recommended to prevent the spread of infection
  • Keep affected areas clean and dry throughout the day
  • Supervise children in the use of this product

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Cinnamomum Zeylanicum (Cinnamon Leaf) Oil, Ethoxydiglycol, Ethyl Macadamiate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive Oil), Trimethylpentanediol/Adipic Acid Copolymer.

DOSAGE & ADMINISTRATION SECTION

Uses

  • Helps cure most fungal nail and skin infections including Athlete's Foot (Tinea Pedis)
  • Effectively relieves cracking, scaling and soreness accompanying the above condition

LABEL FOR BOTTLED PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multi Layer LABELMulti Layer LABEL

Product BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7915 Nail Eraser Box7915 Nail Eraser Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1362937tolnaftate 1 % Topical OilPSN10
1362937tolnaftate 10 MG/ML Topical OilSCD10
1362937tolnaftate 1 % Topical OilSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-410-022025-05-13C16284748780-12cef2736-79c7-d83d-e063-dadaa90ab31fDr. CANUSO Fungal Nail Eraser
76348-410-022025-01-30C16284748780-12cef2736-79c7-d83d-e063-dadaa90ab31fDr. CANUSO Fungal Nail Eraser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-410-02Dr CANUSO fungal nail eraser14 g in 1 BOTTLE, GLASSOIL1410
76348-410-02Dr CANUSO fungal nail eraser1 in 1 BOXOIL110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-410DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, LLC]10Current NDC, Legacy NDC, 2 package rows20250515_2083f9ed-09d6-26e6-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV5
TOLNAFTATEACTIVE MOIETY06KB629TKV5
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ5
CINNAMON LEAF OILINACTIVE INGREDIENTS92U8SQ71V5
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B5
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V15
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E5
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G5
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)INACTIVE INGREDIENT587WKM3S9Q5

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-41076348-410-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYL MACADAMIATEANA2NCS6V1IACT
TOLNAFTATE06KB629TKVACTIB
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CINNAMON LEAF OILS92U8SQ71VIACT
TEA TREE OILVIF565UC2GIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OLIVE OIL6UYK2W1W1EIACT

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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route
10 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BOINTMENT / TOPICAL5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BLOTION / TOPICAL714 mgExact identifier — unii+route
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route
6 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BSYSTEM / TOPICAL1720 mgExact identifier — unii+route
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
6 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BSYSTEM / TOPICAL1720 mgExact identifier — unii+route
10 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BGEL / TOPICAL2500 mgExact identifier — unii+route
10 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BGEL / TOPICAL2500 mgExact identifier — unii+route
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii+route
6 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BLOTION / TOPICAL714 mgExact identifier — unii+route
10 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BOINTMENT / TOPICAL5 %w/wExact identifier — unii+route
10 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
Dr CANUSO fungal nail eraserTOLNAFTATE OILRenu Laboratories, LLC2083f9ed-09d6-26e6-e054-00144ff88e882025-05-13WarningsExact identifier
ndc (package): 76348-410-02
ndc (product): 76348-410
ndc11 (package): 76348041002
spl id: 350a8f7d-e332-0543-e063-6394a90a94c4
spl set id: 2083f9ed-09d6-26e6-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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