TopCare ® Tolnaftate Antifungal Cream

Manufacturer: Topco Associates LLC | Natureplex LLC
Effective date: 2020-12-02
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:34:31

Label at a glance#

ProductTopCare Tolnaftate Antifungal

Active ingredientTolnaftate

Label structure11 sections

Indications and uses

cures most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Dosage and administration

wash affected area and dry thoroughly apply a thin layer over 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 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; for jock itch, use daily fo...

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Contacts and useful links#

PhonePoison Help800-222-1222

PhoneLabel contact866-323-0107

Websitewww.natureplex.com

www.natureplex.com

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

cures most athlete's foot, jock itch, and ringworm
relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant of breastfeeding, ask a health professional before use.

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: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

wash affected area and dry thoroughly
apply a thin layer over 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 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; 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

STORAGE AND HANDLING SECTION

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions or comments?

OTC - QUESTIONS SECTION

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-052-60

TopCare
health_™

PRESCRIPTION STRENGTH

Athlete's Foot Cream

TOLNAFTATE CREAM 1% • ANTIFUNGAL

• OUR PHARMACISTS •
RECOMMEND

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
103951	tolnaftate 1 % Topical Cream	PSN	4
103951	tolnaftate 10 MG/ML Topical Cream	SCD	4
103951	tolnaftate 1 % Topical Cream	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-052-60	2025-01-30	C162847	48780-1	2cef2736-b285-d83d-e063-dadaa90ab31f	TopCare ® Tolnaftate Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-052-60	TopCare Tolnaftate Antifungal	1 in 1 CARTON	CREAM	1		4
36800-052-60	TopCare Tolnaftate Antifungal	14.2 g in 1 TUBE	CREAM	14.2		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-052	TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]	4	Legacy NDC, 2 package rows	20201203_aba4ce9a-ae88-4223-b20f-d7897f7c2232.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Tolnaftate	ACTIVE INGREDIENT	06KB629TKV	1
Tolnaftate	ACTIVE MOIETY	06KB629TKV	1
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	1
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

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

TopCare Tolnaftate Antifungal
Tolnaftate
Butylated Hydroxytoluene
Polyethylene glycol 400
Polyethylene glycol 3350
titanium dioxide
petrolatum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-052	36800-052-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Tolnaftate	06KB629TKV	ACTIB
Butylated Hydroxytoluene	1P9D0Z171K	IACT
Polyethylene glycol 400	B697894SGQ	IACT
Polyethylene glycol 3350	G2M7P15E5P	IACT
titanium dioxide	15FIX9V2JP	IACT
petrolatum	4T6H12BN9U	IACT

Source Document#

Source XML · Source PDF

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 3 · 154 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, EXTENDED RELEASE / ORAL		61 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SUBCUTANEOUS	2.88 %w/v		Exact identifier — unii candidate 28 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	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRAMUSCULAR		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRA-ARTICULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SOFT TISSUE		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 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
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 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	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CREAM / TOPICAL		396 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRAVENOUS	0.5 ml		Exact identifier — unii candidate 28 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
cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04			aba4ce9a-ae88-4223-b20f-d7897f7c2232	2020-12-02	Warnings	Exact identifier spl id: cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04 spl set id: aba4ce9a-ae88-4223-b20f-d7897f7c2232

Reported adverse events (FAERS/openFDA)#

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

TopCare ® Tolnaftate Antifungal Cream

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

OTC - DO NOT USE SECTION

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#