ASTONEA Antifungal Cream TOLNAFLATE

Manufacturer: ASTONEA LABS PRIVATE LIMITED
Effective date: 2024-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:09:25

Label at a glance#

ProductASTONEA Antifungal Cream TOLNAFLATE

Active ingredientTOLNAFTATE

Label structure10 sections

Indications and uses

proven clinically 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

adults and children 2 years of age and over: 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 to prevent athlete's foot, apply once or twice daily (morning and...

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if tube seal under cap is broken

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-326-1313

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

proven clinically 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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs
there is no improvement within 4 weeks

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and over:

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
to prevent athlete's foot, apply once or twice daily (morning and/or night)
this product is not effective on the scalp or nails

Children under 2 years of age: consult a physician

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, propylene glycol, sodium metabisulfite, water

Questions?

OTC - QUESTIONS SECTION

Toll Free 1-866-326-1313

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-934-01	ASTONEA Antifungal Cream TOLNAFLATE	35.4 g in 1 TUBE	CREAM	35.4		1
77338-934-01	ASTONEA Antifungal Cream TOLNAFLATE	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-934	ASTONEA ANTIFUNGAL CREAM TOLNAFLATE (TOLNAFTATE) CREAM [ASTONEA LABS PRIVATE LIMITED]	1	2 package rows	20240307_12efcacd-2066-f25c-e063-6294a90a4dc0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

ASTONEA Antifungal Cream TOLNAFLATE
Tolnaftate
PETROLATUM
CETETH-20
CETOSTEARYL ALCOHOL
CHLOROCRESOL
LIGHT MINERAL OIL
PROPYLENE GLYCOL
WATER
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE
EDETATE DISODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-934	77338-934-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	IACT
CETETH-20	I835H2IHHX	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CHLOROCRESOL	36W53O7109	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE	BWZ7K44R51	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
TOLNAFTATE	06KB629TKV	ACTIB

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
12efc4ba-025b-eb55-e063-6294a90a9c3e			12efcacd-2066-f25c-e063-6294a90a4dc0	2024-03-05	Warnings	Exact identifier spl id: 12efc4ba-025b-eb55-e063-6294a90a9c3e spl set id: 12efcacd-2066-f25c-e063-6294a90a4dc0

Reported adverse events (FAERS/openFDA)#

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