Flexitol Anti Fungal

Manufacturer: LaCorium Health International Pty Ltd
Effective date: 2012-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:34:03

Label at a glance#

ProductFlexitol Anti Fungal

Active ingredientUndecylenic acid

Label structure10 sections

Indications and uses

For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

Dosage and administration

Read all directions and warnings before use Clean affected area with soap and warm water and dry thoroughly Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor 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. For Athlete's Foot...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-866-478-3338

Websitewww.flexitol.com

www.flexitol.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Extremely flammable
Keep away from fire or flame
Avoid smoking during use and until product has dried

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 right away

OTC - STOP USE SECTION

Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks

Directions

DOSAGE & ADMINISTRATION SECTION

Read all directions and warnings before use
Clean affected area with soap and warm water and dry thoroughly
Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor
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.
For Athlete's Foot and Ringworm use daily for 4 weeks. If condition persists longer, consult a doctor.
Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
Supervise children in the use of this product
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 Barbadensis Leaf Juice, Butylated Hydroxytoluebe, Eucalyptus Globulus Oil, Hydroxypropyl Methylcellulose, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol Acetate, Urea, Water

Comments or questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flexitol_®

Anti-Fungal
Liquid

Treats Fungus

APPROVED
AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

Clinically Proven

Easy brush-on APPLICATOR

WITH UREA, ALOE VERA, VITAMIN E,
TEA TREE & EUCALYPTUS OILS

NDC: 43251-3351

1 fl oz (30ml)

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998329	undecylenic acid 25 % Topical Solution	PSN	3
998329	undecylenic acid 250 MG/ML Topical Solution	SCD	3
998329	undecylenic acid 25 % Topical Solution	SY	3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43251-3351-1	2019-11-27	C162847	48780-1	9855d018-ddc6-cd31-e053-dbdaa90ab51a	Flexitol ® Anti-Fungal Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43251-3351-1	Flexitol Anti Fungal	1 in 1 CARTON	LIQUID	1		3
43251-3351-1	Flexitol Anti Fungal	30 mL in 1 BOTTLE	LIQUID	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43251-3351	FLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]	3	Legacy NDC, 2 package rows	20121222_39f54d88-4e35-4f26-a988-42807d7e010e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Undecylenic acid	ACTIVE INGREDIENT	K3D86KJ24N	3
Undecylenic acid	ACTIVE MOIETY	K3D86KJ24N	3
.Alpha.-Tocopherol Acetate, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	3
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	3
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	3
Eucalyptus Oil	INACTIVE INGREDIENT	2R04ONI662	3
Hypromellose 2906 (4000 MPA.S)	INACTIVE INGREDIENT	5EYA69XGAT	3
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	3
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	3
Urea	INACTIVE INGREDIENT	8W8T17847W	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Flexitol Anti Fungal
Undecylenic acid
Isopropyl Alcohol
Water
Urea
Eucalyptus Oil
Hypromellose 2906 (4000 MPA.S)
Tea Tree Oil
.Alpha.-Tocopherol Acetate, DL-
Aloe Vera Leaf
Butylated Hydroxytoluene

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43251-3351	43251-3351-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Undecylenic acid	K3D86KJ24N	ACTIB
Isopropyl Alcohol	ND2M416302	IACT
Water	059QF0KO0R	IACT
Urea	8W8T17847W	IACT
Eucalyptus Oil	2R04ONI662	IACT
Hypromellose 2906 (4000 MPA.S)	5EYA69XGAT	IACT
Tea Tree Oil	VIF565UC2G	IACT
.Alpha.-Tocopherol Acetate, DL-	WR1WPI7EW8	IACT
Aloe Vera Leaf	ZY81Z83H0X	IACT
Butylated Hydroxytoluene	1P9D0Z171K	IACT

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 · 57 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
.Alpha.-Tocopherol Acetate, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	AEROSOL, FOAM / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)	HYPROMELLOSE 2906 (4000 MPA.S)	5EYA69XGAT	SUSPENSION / ORAL		184 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)	HYPROMELLOSE 2906 (4000 MPA.S)	5EYA69XGAT	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Urea	UREA	8W8T17847W	INSERT / VAGINAL		50 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)	HYPROMELLOSE 2906 (4000 MPA.S)	5EYA69XGAT	GRANULE, DELAYED RELEASE / ORAL	33.2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Urea	UREA	8W8T17847W	CREAM / VAGINAL	0.64 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Urea	UREA	8W8T17847W	TABLET, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Urea	UREA	8W8T17847W	SYSTEM / TOPICAL		840 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
.Alpha.-Tocopherol Acetate, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Urea	UREA	8W8T17847W	TABLET, COATED / ORAL	0.02 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)	HYPROMELLOSE 2906 (4000 MPA.S)	5EYA69XGAT	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
Eucalyptus Oil	EUCALYPTUS OIL	2R04ONI662	SYRUP / ORAL	NA		Exact identifier — unii candidate
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)	HYPROMELLOSE 2906 (4000 MPA.S)	5EYA69XGAT	TABLET / ORAL	50 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / AURICULAR (OTIC)		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Urea	UREA	8W8T17847W	DOUCHE / VAGINAL	8 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Urea	UREA	8W8T17847W	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)	HYPROMELLOSE 2906 (4000 MPA.S)	5EYA69XGAT	CAPSULE / ORAL		282 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii candidate 9 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7a47e254-5846-47c7-8a7e-aad2484846ff			39f54d88-4e35-4f26-a988-42807d7e010e	2012-12-20	Warnings	Exact identifier spl id: 7a47e254-5846-47c7-8a7e-aad2484846ff spl set id: 39f54d88-4e35-4f26-a988-42807d7e010e

Reported adverse events (FAERS/openFDA)#

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