FDA.reportPublic FDA data

Flexitol Medicated Foot Cream

Manufacturer
LaCorium Health International Pty Ltd | Jalco Pharmaceuticals Pty Ltd
Effective date
2012-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:46

Label at a glance#

ProductFlexitol Medicated Foot
Active ingredientTolnaftate
Label structure11 sections

Indications and uses

Clinically proven to prevent Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) with daily use For effective relief of symptoms of Athlete's Foot, including itching, burning, cracking, scaling and discomfort associated with this condition.

Dosage and administration

Clean the affected area and dry thoroughly Apply a thin layer of the product over the 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 the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer c...

Storage and handling

Store between 50°- 86°F in a dry place

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

  • Clinically proven to prevent Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) with daily use
  • For effective relief of symptoms of Athlete's Foot, including itching, burning, cracking, scaling and discomfort associated with this condition.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • Do not use on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

  • For External Use Only
  • Avoid contact with eyes

OTC - STOP USE SECTION

  • If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly
  • Apply a thin layer of the product over the 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 the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use daily for 4 weeks. If condition persists longer consult a doctor.
  • To prevent Athlete's Foot, apply once or twice daily (morning and/or night)
  • This product is not effective on the scalp or nails
  • Replace cap and tighten after each use.

Other Information

STORAGE AND HANDLING SECTION

  • Store between 50°- 86°F in a dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe, Benzalkonium Chloride, Cetearyl Alcohol, Ceteth-20, Cetyl Alcohol, Glycerin, Lavandula, Angustifolia (Lavender) Oil, Menthol, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Sodium Phosphate, Tocopherol, Urea, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call Toll Free 1-866-478-3338
usainfo@flexitol.com
www.flexitol.com

SPL UNCLASSIFIED SECTION

USA DISTRIBUTOR:
LaCorium Health USA Inc.,
Boca Raton, Florida 33487

MANUFACTURED FOR:
LaCorium Health International Pty Ltd.,
Level 14, Tower 2,
101 Grafton Street,
Bondi Junction NSW 2022, Australia

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flexitol®

Medicated
Foot Cream

For treatment of
athlete's foot

Before

After 2 Weeks

APPROVED

AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

With Aloe & Vitamin E

DIABETIC FRIENDLY

Net Wt 2 oz (56 g)

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN1
103951tolnaftate 10 MG/ML Topical CreamSCD1
103951tolnaftate 1 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43251-3340-12019-11-27C16284748780-19855d018-eedc-cd31-e053-dbdaa90ab51aFlexitol Medicated Foot Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43251-3340-1Flexitol Medicated Foot1 in 1 CARTONCREAM11
43251-3340-1Flexitol Medicated Foot56 g in 1 TUBECREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43251-3340FLEXITOL MEDICATED FOOT (TOLNAFTATE) CREAM [LACORIUM HEALTH INTERNATIONAL PTY LTD]1Legacy NDC, 2 package rows20121121_c31da255-e671-41e3-8607-efbb6973163c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKV1
TolnaftateACTIVE MOIETY06KB629TKV1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X1
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W71
Ceteth-20INACTIVE INGREDIENTI835H2IHHX1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
Cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Lavender OilINACTIVE INGREDIENTZBP1YXW0H81
MentholINACTIVE INGREDIENTL7T10EIP3A1
Mineral OilINACTIVE INGREDIENTT5L8T28FGP1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V31
Sodium phosphateINACTIVE INGREDIENTSE337SVY371
TocopherolINACTIVE INGREDIENTR0ZB2556P81
UreaINACTIVE INGREDIENT8W8T17847W1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-334043251-3340-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tolnaftate06KB629TKVACTIB
Urea8W8T17847WIACT
Cetostearyl Alcohol2DMT128M1SIACT
Mineral OilT5L8T28FGPIACT
GlycerinPDC6A3C0OXIACT
Propylene glycol6DC9Q167V3IACT
Petrolatum4T6H12BN9UIACT
Polysorbate 60CAL22UVI4MIACT
Ceteth-20I835H2IHHXIACT
Cetyl alcohol936JST6JCNIACT
MentholL7T10EIP3AIACT
Sodium phosphateSE337SVY37IACT
Benzalkonium chlorideF5UM2KM3W7IACT
TocopherolR0ZB2556P8IACT
Lavender OilZBP1YXW0H8IACT
Aloe Vera LeafZY81Z83H0XIACT
Water059QF0KO0RIACT

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 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Ceteth-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii candidate
4 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS24.75 mgExact identifier — unii candidate
24 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37INJECTION / INTRABURSALADJ PHExact identifier — unii candidate
24 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR24.75 mgExact identifier — unii candidate
24 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
Benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37SOLUTION / OPHTHALMIC0.81 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37CONCENTRATE / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MentholMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37SUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Sodium phosphateSODIUM PHOSPHATESE337SVY37INJECTION / INTRADERMAL0.2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, COATED / ORAL0.02 mgExact identifier — unii candidate
7 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
UreaUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 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
32d36fb9-913b-4581-a2af-dc45211a4a4bc31da255-e671-41e3-8607-efbb6973163c2012-11-12WarningsExact identifier
spl id: 32d36fb9-913b-4581-a2af-dc45211a4a4b
spl set id: c31da255-e671-41e3-8607-efbb6973163c

Reported adverse events (FAERS/openFDA)#

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