TOLNAFTATE ANTIFUNGAL

Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-29
Label type
HUMAN OTC DRUG LABEL
Version
100
Source
full-release
Hydrated at
2026-06-01 00:08:01

Label at a glance#

ProductTOLNAFTATE ANTIFUNGAL
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

• for effective treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) • for effective relief of itchy, scaly skin between the toes • clears up most athlete’s foot infection and with daily use helps keep it from coming back

Dosage and administration

• shake well before use • clean the affected area and dry thoroughly • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • supervise children in the use of this product • use daily for 4 weeks. If condition persists longer, consult a doctor. For athlete's foot • pay special attention to the spaces between the toes • wear well-fitting ventilated shoes • ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

USES

INDICATIONS & USAGE SECTION

• for effective treatment of most athlete’s foot (tinea pedis)

and ringworm (tinea corporis)
• for effective relief of itchy, scaly skin between the toes
• clears up most athlete’s foot infection and with daily
use helps keep it from coming back

WARNINGS

WARNINGS SECTION

For external use only
Do not use on children under 2 years of age unless
directed by a doctor.
When using this product avoid contact with the eyes
Stop use and consult a doctor if
• 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 Poison Control
Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• shake well before use

• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area
twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• use daily for 4 weeks. If condition persists longer,
consult a doctor.

For athlete's foot

• pay special attention to the spaces between the toes
• wear well-fitting ventilated shoes
• change shoes and socks at least once daily
• to prevent athlete’s foot, clean and dry feet thoroughly.
Apply as above once or twice daily.
This product is not effective on the scalp or nails.

Other Information

OTHER SAFETY INFORMATION

• store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch and talc

HOW SUPPLIED

How Supplied Section

NDC: 71335-2249-1: 45 g in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate 1% Powder #45

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313422tolnaftate 1 % Topical PowderPSN100
313422tolnaftate 0.01 MG/MG Topical PowderSCD100
313422tolnaftate 1 % Topical PowderSY100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2249-1TOLNAFTATE ANTIFUNGAL45 g in 1 BOTTLE, DISPENSINGPOWDER45100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2249TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240130_fbbd159c-217e-46d3-963c-ba0bd1e9bbe8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2249-1GM - Gram71335-2249471e0695-f59d-40b5-9830-22e56b6e12bf12024-03-12
57896-199-45GM - Gram57896-1998484e728-4ce2-4941-82cd-37c07f868cb412017-12-14

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-224971335-2249-1
57896-199

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TOLNAFTATE06KB629TKVACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
ndc (package): 71335-2249-1
ndc (product): 71335-2249
ndc11 (package): 71335224901
spl id: 338b2c92-5505-4320-81d5-b5d3548f27e8
spl set id: fbbd159c-217e-46d3-963c-ba0bd1e9bbe8
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
ndc (product): 57896-199

Reported adverse events (FAERS/openFDA)#

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