FDA.reportPublic FDA data

Nailene Antifungal Treatment

Manufacturer
Pacific World Corporation
Effective date
2014-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:40:35

Label at a glance#

ProductNailene Antifungal Treatment
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

Cures most fungal skin infections, including athlete's foot (tinea pedis) and ringworm (tinea corporis) Effectively relieves itching, burning, cracking and scaling accompanying such conditions

Dosage and administration

Clean affected area with soap and warm water and dry thoroughly Apply a thin layer two times a day (mornings and evenings) to affected area especially the space between and around toes For athlete's foot, use daily for four weeks or as directed by a physician Allow solution to soak into skin or rub in to dry more quickly before putting on socks This product is not effective on scalp or nails. Following a proper fo...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Cures most fungal skin infections, including athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Effectively relieves itching, burning, cracking and scaling accompanying such conditions

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • near the mouth or eyes
  • with known sensitivities to any listed ingredients
  • on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this product avoid eye contact. If accidental eye contact occurs, rinse thoroughly with water for 10-15 minutes.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation occurs, or if no improvement is seen after four weeks.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant/breast-feeding, consult a health professional before using.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean affected area with soap and warm water and dry thoroughly
  • Apply a thin layer two times a day (mornings and evenings) to affected area especially the space between and around toes
  • For athlete's foot, use daily for four weeks or as directed by a physician
  • Allow solution to soak into skin or rub in to dry more quickly before putting on socks
  • This product is not effective on scalp or nails.
  • Following a proper foot hygiene regimen along with wearing well fitting, ventilated shoes and clean socks that are changed at least daily is helpful in preventing future infections

Other information

SPL UNCLASSIFIED SECTION

You may report questions or adverse reaction from using this product to 1(541)-476-3178, 8 am to 5 pm (M–F), PST.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglycerides, Isopropyl Palmitate, Polyquaternium 37, Propylene Glycol, Dicaprylate Dicaprate, PPG-1 Trideceth-6, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Phemerol Chloride, Cetrimonium Chloride, Allantoin, Didecyldimonium Chloride, Quaternium-15.

SPL UNCLASSIFIED SECTION

Imported & Distributed by:

UK/R.-U.: Pacific World Ltd.,
Stoke-on-Trent, Staffordshire. ST4 2 PJ
Australia: Creative Brands PTY LTD
30 Bando Road, Springvale, VIC 3171
South Africa: Indigo Cosmetics, Cape Town, 7460
New Zealand: BDM Grange, Auckland

PRINCIPAL DISPLAY PANEL - 18 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

new

61100

nailene®

DOCTOR
FORMULATED

MAXIMUM STRENGTH
ANTIFUNGAL
TREATMENT

Powered by
MYCOCIDE ®

For finger and
toe areas

No need to remove
nail polish or acrylics

INCLUDES:

2 Extra-Coarse Nail Grinders

NET WT .6 FL OZ (18 mL) Antifungal Liquid

Principal Display Panel - 18 mL Bottle Carton
Principal Display Panel - 18 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN3
313423tolnaftate 10 MG/ML Topical SolutionSCD3
313423tolnaftate 1 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60193-102-022020-01-31C16284748780-19d75b9d0-0d4e-f424-e053-dadaa90a57ceNailene ® Antifungal Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60193-102-02Nailene Antifungal Treatment18 mL in 1 BOTTLE, WITH APPLICATORLIQUID183
60193-102-02Nailene Antifungal Treatment1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60193-102NAILENE ANTIFUNGAL TREATMENT (TOLNAFTATE) LIQUID [PACIFIC WORLD CORPORATION]3Legacy NDC, 2 package rows20141021_ae22a4f1-77bd-4b37-bf3c-24f402e15bf0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV3
TOLNAFTATEACTIVE MOIETY06KB629TKV3
ALLANTOININACTIVE INGREDIENT344S277G0Z3
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057443
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBP3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX3
COCAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENTM4SL82J7HK3
DIDECYLDIMONIUM CHLORIDEINACTIVE INGREDIENTJXN40O9Y9B3
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MS3
POLYQUATERNIUM-37 (3000 MPA.S)INACTIVE INGREDIENTHU373G0YSU3
PPG-1 TRIDECETH-6INACTIVE INGREDIENT1K7417JX6Q3
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEINACTIVE INGREDIENTO4446S9CRA3
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM03
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60193-10260193-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
POLYQUATERNIUM-37 (3000 MPA.S)HU373G0YSUIACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
ALLANTOIN344S277G0ZIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
QUATERNIUM-15E40U03LEM0IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM / TRANSDERMAL2 mgExact identifier — unii candidate
8 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION/ DROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0LOTION / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAVENOUS1 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM, EXTENDED RELEASE / TRANSDERMAL187.5 mgExact identifier — unii candidate
8 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
e078e140-0b97-46e9-99c8-de9c5593a5bbae22a4f1-77bd-4b37-bf3c-24f402e15bf02014-10-17WarningsExact identifier
spl id: e078e140-0b97-46e9-99c8-de9c5593a5bb
spl set id: ae22a4f1-77bd-4b37-bf3c-24f402e15bf0

Reported adverse events (FAERS/openFDA)#

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