Perrigo Tolnaftate Cream USP, 1% Drug Facts

Manufacturer: A-S Medication Solutions
Effective date: 2017-09-07
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:12:20

Label at a glance#

ProductTolnaftate

Active ingredientTOLNAFTATE

Label structure9 sections

Indications and uses

proven clinically effective in the treatment of most athlete’s foot (tinea pedis) ringworm (tinea corporis) helps prevent most athlete’s foot with daily use for effective relief of itching burning 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 lasts longer, ask a doctor. to prevent athlete’s foot, apply once or twi...

Storage and handling

store at 68°-77°F (20°-25°C)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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 unless directed by 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
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 lasts 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

Other information

STORAGE AND HANDLING SECTION

store at 68°-77°F (20°-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, carbomer homopolymer type C, monoamylamine, PEG-400, propylene glycol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Tolnaftate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Data Matrix	(01)00050090016108(17)991231(10)9987654(21)AA000000	GTIN-14: 00050090016108 GTIN-12: 050090016108 UPC-A: 050090016108 EAN-13: 0050090016108 GTIN storage (14 digits): 00050090016108	lbl500900161.jpg
Data code	Code 128	075600099876541299		lbl500900161.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-032-01	GM - Gram	45802-032	fc748562-3af7-4e2e-bf54-ed67b8c6a27c	1	2012-07-24
45802-032-03	GM - Gram	45802-032	bfec7833-97fa-4831-8d12-b519709b6fad	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Tolnaftate
BUTYLATED HYDROXYTOLUENE
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
TITANIUM DIOXIDE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-0161	50090-0161-0
45802-032

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
PROPYLENE GLYCOL	6DC9Q167V3	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT

Source Document#

Source XML

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
ecc077c4-d280-486a-9366-d8bbed05a235			c86572bf-1541-40bf-b168-7291954144ee	2017-09-07	Warnings	Exact identifier spl id: ecc077c4-d280-486a-9366-d8bbed05a235 spl set id: c86572bf-1541-40bf-b168-7291954144ee

Reported adverse events (FAERS/openFDA)#

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