Tolnaftate

Manufacturer: Major Pharmaceuticals
Effective date: 2024-11-12
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 20:49:35

Label at a glance#

ProductTolnaftate

Active ingredientTOLNAFTATE

Label structure11 sections

Indications and uses

for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) for effective relief of itchy, scaly skin between the toes clears up most athlete's foot infection and with daily use helps keep it from coming back

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 use daily for 4 weeks. If condition persists longer, consult a doctor pay special attention to the spaces between the toes wear well fitting ventilated shoes change shoes and socks at least onc...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate USP 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
for effective relief of itchy, scaly skin between the toes
clears up most athlete's foot infection and with daily use helps keep it from coming back

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
irritation occurs or if there is no improvement within 2 weeks (for jock itch)

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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

use daily for 4 weeks. If condition persists longer, consult a doctor
pay special attention to the spaces between the toes
wear well fitting ventilated shoes
change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 15°-30°C (59°-86°F)
Lot No. and Exp date: see crimp on tube or see box

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic, White Petrolatum

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Principal Display Panel – 0.5 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^® *Compare to Active Ingredient of Tinactin®

NDC 0904-0722-36

Antifungal

Cream (Tolnaftate 1%) N309040722362

CURES ATHLETE'S FOOT, *This product is not manufactured or

JOCK ITCH AND RINGWORM distributed by Schering-Plough Healthcare

Relives Burning and Itching Products, Inc. owner of the registered

• Odorless • Greaseless • Non-Staining trademark, Tinactin®

Net Wt. 0.5 OZ (14.18 g)

Principal Display Panel – 0.5 oz Tube

Principal Display Panel – 0.5 oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^® NDC 0904-0722-36

Antifungal *Compare to Active Ingredient of Tinactin®

Cream

(Tolnaftate 1%) Net Wt. 0.5 OZ (14.18 g)

Principal Display Panel – 0.5 oz Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-0722-36	2021-12-01	C162847	48780-1	ba0f9c33-54b6-a910-e053-dadaa90a0b85	5a05dc53-f817-40bd-9355-a3266afb1179
0904-0722-36	2021-01-29	C162847	48780-1	ba0f9c33-54b6-a910-e053-dadaa90a0b85	5a05dc53-f817-40bd-9355-a3266afb1179

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-0722	TOLNAFTATE CREAM [MAJOR PHARMACEUTICALS]	4	Legacy NDC	20241114_5a05dc53-f817-40bd-9355-a3266afb1179.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0722-36	GM - Gram	0904-0722	26b64571-2bd2-4d74-afdc-5eae458205bb	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	1
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	1
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Tolnaftate
WATER
CETOSTEARYL ALCOHOL
CETETH-20
CHLOROCRESOL
MINERAL OIL
PETROLATUM
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
PROPYLENE GLYCOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-0722	0904-0722-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
WATER	059QF0KO0R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20	I835H2IHHX	IACT
CHLOROCRESOL	36W53O7109	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	IACT
PROPYLENE GLYCOL	6DC9Q167V3	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 4 · 185 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INSERT / INTRAOCULAR	0.01 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	18.81 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.2 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SOLUTION / INTRAMUSCULAR	0.62 %w/v		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CHLOROCRESOL	CHLOROCRESOL	36W53O7109	CREAM, AUGMENTED / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / ORAL		120 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SUSPENSION/ DROPS / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 41 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRA-ARTICULAR		13 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 41 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		161 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	FILM / BUCCAL	1.09 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	TABLET, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 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
485aa6ab-9aec-14c4-e063-6394a90a9cb4			5a05dc53-f817-40bd-9355-a3266afb1179	2026-01-14	Warnings	Exact identifier spl set id: 5a05dc53-f817-40bd-9355-a3266afb1179

Reported adverse events (FAERS/openFDA)#

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

Tolnaftate

Label at a glance#

Indications and uses

Dosage and administration

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

OTC - WHEN USING SECTION

Stop use and ask a doctor if

Keep this and all drugs out of the reach of children.

Directions

Other information

Inactive ingredients

Questions?

Principal Display Panel – 0.5 oz Tube

Principal Display Panel – 0.5 oz Carton

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#