Tolnaftate

Manufacturer: Kareway Product, Inc.
Effective date: 2023-02-17
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:35:40

Label at a glance#

ProductTolnaftate

Active ingredientTOLNAFTATE

Label structure8 sections

Indications and uses

clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevnet most athlete's foot from recurring when used daily effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Dosage and administration

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to 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, ask a doctor to prevent athlete's foot, apply once of twic...

Storage and handling

store between 2° and 30°C (36° and 86°F)

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
helps prevnet most athlete's foot from recurring when used daily
effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Warning

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs
there is no improvement within 4 weeks

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
supervise children in the use of this product
for athlete's foot, pay special attention to 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, ask a doctor
to prevent athlete's foot, apply once of twice daily (morning and/or night)
this product is not effective on the scalp or nails

Other Information

STORAGE AND HANDLING SECTION

store between 2° and 30°C (36° and 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Cetyl alcohol, Cholesterol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate image of carton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67510-0057-1	2023-02-24	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-5	2023-02-24	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-6	2023-02-24	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-1	2023-01-30	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-5	2023-01-30	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-6	2023-01-30	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-1	2020-06-08	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-5	2020-06-08	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-6	2020-06-08	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-1	2020-01-31	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-5	2020-01-31	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz
67510-0057-6	2020-01-31	C162847	48780-1	9d75b9d0-50cb-f424-e053-dadaa90a57ce	Pure-Aid Tolnaftate 1oz

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Tolnaftate	ACTIVE INGREDIENT	06KB629TKV	1
Tolnaftate	ACTIVE MOIETY	06KB629TKV	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
Paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Tolnaftate
ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
PARAFFIN
STEARIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0057	67510-0057-1, 67510-0057-6, 67510-0057-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PARAFFIN	I9O0E3H2ZE	IACT
STEARIC ACID	4ELV7Z65AP	IACT
WATER	059QF0KO0R	IACT
TOLNAFTATE	06KB629TKV	ACTIB

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 · 192 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Stearic acid	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic acid	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f4ee88a8-bf3d-454f-e053-2a95a90ae2a1			c5046fb8-b802-49df-81a8-3f486e63f367	2023-02-17	Warnings	Exact identifier spl id: f4ee88a8-bf3d-454f-e053-2a95a90ae2a1 spl set id: c5046fb8-b802-49df-81a8-3f486e63f367

Reported adverse events (FAERS/openFDA)#

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