Family Care Tolnaftate Cream 1oz (502 TG, 2018)

Manufacturer: United Exchange Corp.
Effective date: 2021-12-22
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-05-31 23:45:51

Label at a glance#

ProductFamily Care Tolnaftate

Active ingredientTOLNAFTATE

Label structure12 sections

Storage and handling

Other information store between 20° to 25°C (68° and 77°F) Lot No. and Exp. Date: see box or see crimp of tube

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Tolnaftate 1%........................................................ Antifungal

OTC - PURPOSE SECTION

Uses

proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
helps prevent most athlete's foot with daily use
for effective relief of itching, burning and cracking

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor

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 immediately

INDICATIONS & USAGE SECTION

Directions

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 or twice daily (morning and/or night)
this product is not effective on the scalp or nails

STORAGE AND HANDLING SECTION

Other information

store between 20° to 25°C (68° and 77°F)
Lot No. and Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ingredients ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium, phosphate, dihydrate, propylene glycol, purified water, white petrolatum

DOSAGE & ADMINISTRATION SECTION

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
103951	tolnaftate 1 % Topical Cream	PSN	9
103951	tolnaftate 10 MG/ML Topical Cream	SCD	9
103951	tolnaftate 1 % Topical Cream	SY	9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65923-502-28	2023-01-30	C162847	48780-1	f386c649-d1d2-0266-e053-dadaa90a7c1a	Family Care Tolnaftate Cream 1oz (502 TG, 2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65923-502-28	Family Care Tolnaftate	1 in 1 CARTON	CREAM	1		9
65923-502-28	Family Care Tolnaftate	28 g in 1 TUBE	CREAM	28		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65923-502	FAMILY CARE TOLNAFTATE (TOLNAFTATE) CREAM [UNITED EXCHANGE CORP.]	9	Legacy NDC, 2 package rows	20211223_2c7f54b1-7c61-43c1-b191-60f12d3ef276.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Tolnaftate	ACTIVE INGREDIENT	06KB629TKV	5
Tolnaftate	ACTIVE MOIETY	06KB629TKV	5
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	5
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	5
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	5
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	5

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Family Care Tolnaftate
Tolnaftate
CETETH-20
CETOSTEARYL ALCOHOL
CHLOROCRESOL
PARAFFIN
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
PROPYLENE GLYCOL
WATER
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65923-502	65923-502-28

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
CETETH-20	I835H2IHHX	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CHLOROCRESOL	36W53O7109	IACT
PARAFFIN	I9O0E3H2ZE	IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
PETROLATUM	4T6H12BN9U	IACT
TOLNAFTATE	06KB629TKV	ACTIB

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 1 · 57 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	1.6 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	SOLUTION / ORAL		63 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION, SOLUTION / INTRAVENOUS		115 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION, SOLUTION / INTRATHECAL	0.01 %w/v		Exact identifier — unii candidate 13 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION, SOLUTION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 13 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	SOLUTION/ DROPS / OPHTHALMIC	1.15 %w/v		Exact identifier — unii candidate 13 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	LOTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 13 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 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, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	SOLUTION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CHLOROCRESOL	CHLOROCRESOL	36W53O7109	CREAM, AUGMENTED / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	CREAM / TOPICAL		429 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	GEL / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION / INTRAVENOUS	12.8 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION / INTRAMUSCULAR	12.8 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	SUSPENSION / ORAL		140 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CHLOROCRESOL	CHLOROCRESOL	36W53O7109	CREAM / TOPICAL		5 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	1.3 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 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
d3c490cb-5753-7bc8-e053-2995a90a497e			2c7f54b1-7c61-43c1-b191-60f12d3ef276	2021-12-22	Warnings	Exact identifier spl id: d3c490cb-5753-7bc8-e053-2995a90a497e spl set id: 2c7f54b1-7c61-43c1-b191-60f12d3ef276

Reported adverse events (FAERS/openFDA)#

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