CR-371059 Tolnaftate 1% Cream

Manufacturer: Rugby Laboratories
Effective date: 2026-10-06
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: daily-update
Hydrated at: 2026-10-10 01:03:52

Label at a glance#

ProductCR-371059 Tolnaftate 1% Cream

Active ingredientTOLNAFTATE

Label structure9 sections

Indications and uses

• Proven effective in the treatment of most 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

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...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• Proven effective in the treatment of most 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

WARNINGS SECTION

• For External Use Only

• This product is not effective on the scalp or nails

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away

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

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 or twice daily (morning and/or night)

Other Information

OTHER SAFETY INFORMATION

Store between 20° to 25ºC (68º to 77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

Questions and Comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR-371059 BX Master

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0305361315436	GTIN-13: 0305361315436 EAN-13: 0305361315436 GTIN-12: 305361315436 UPC-A: 305361315436 GTIN storage (14 digits): 00305361315436	CR-371059 BX MASTER (R210301-1).jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1315-43	GM - Gram	0536-1315	4b7974c0-320f-4daa-8ca0-6579735997b5	1	2021-11-09

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

CR-371059 Tolnaftate 1% Cream
TOLNAFTATE
CETETH-20
MINERAL OIL
CHLOROCRESOL
PROPYLENE GLYCOL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
PETROLATUM
CETOSTEARYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-1315	0536-1315-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
CETETH-20	I835H2IHHX	IACT
MINERAL OIL	T5L8T28FGP	IACT
CHLOROCRESOL	36W53O7109	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	IACT
PETROLATUM	4T6H12BN9U	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2025-11-25	full-release	2026-06-01 01:18:08

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
CR-371059 Tolnaftate 1% Cream	CR-371059 TOLNAFTATE 1% CREAM	Rugby Laboratories	b95a76ad-9b4c-692a-e053-2995a90abd1a	2025-11-25	Warnings	Exact identifier ndc (package): 0536-1315-43 ndc (product): 0536-1315 ndc11 (package): 00536131543 spl set id: b95a76ad-9b4c-692a-e053-2995a90abd1a

Reported adverse events (FAERS/openFDA)#

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