Tolnaftate

Manufacturer: A-S Medication Solutions
Effective date: 2023-03-02
Label type: HUMAN OTC DRUG LABEL
Version: 18
Source: legacy-cache
Hydrated at: 2026-08-01 21:35:12

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0160

NDC: 50090-0160-0 14.18 g in a TUBE / 1 in a CARTON

TOLNAFTATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0160-0	2023-02-07	C162847	48780-1	f386c649-f3aa-0266-e053-dadaa90a7c1a	98d95cd0-e7f6-4354-8374-ea5555e5acaa
50090-0160-0	2023-01-30	C162847	48780-1	f386c649-f3aa-0266-e053-dadaa90a7c1a	98d95cd0-e7f6-4354-8374-ea5555e5acaa

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0160-0	GM - Gram	50090-0160	7a3531f3-2fee-45ee-96da-19e2def8c310	1	2018-08-13
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
50090-0160	50090-0160-0
0904-0722

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	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SUSPENSION / OPHTHALMIC	0.65 %w/w		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION / INTRAVASCULAR	0.01 %w/v		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
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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 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
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION / INTRAMUSCULAR		13 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / AURICULAR (OTIC)	0.13 %w/w		Exact identifier — unii candidate 41 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	18.81 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 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
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / INTRAVESICAL	0.12 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRALESIONAL		10 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
CHLOROCRESOL	CHLOROCRESOL	36W53O7109	CREAM / TOPICAL		5 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 4 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	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 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	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	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
a3ae8a91-b1e5-4b0f-9d52-438b92cc10ce			98d95cd0-e7f6-4354-8374-ea5555e5acaa	2024-09-18	Warnings	Exact identifier spl set id: 98d95cd0-e7f6-4354-8374-ea5555e5acaa

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?

HOW SUPPLIED

TOLNAFTATE

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#