FDA.reportPublic FDA data

Family Wellness Athletes Foot Tolnaftate 1 Cream

Manufacturer
Family Dollar Stores, Inc
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:59

Label at a glance#

ProductFamily Wellness Athletes Foot Tolnaftate 1 Cream
Active ingredientTOLNAFTATE
Label structure8 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

wash the 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 the 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Funga

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.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor.

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 Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash the 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 the 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.

Other info rmation

SPL UNCLASSIFIED SECTION

  • store at room temperature 20°-25°C (68°-77°F).
  • lot no & expiration date: see box or crimp of tube

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN3
103951tolnaftate 10 MG/ML Topical CreamSCD3
103951tolnaftate 1 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-991-002025-02-07C16284748780-12cef2736-6246-d83d-e063-dadaa90ab31fFamily Wellness Athletes Foot Tolnaftate 1% Cream
55319-991-002025-01-30C16284748780-12cef2736-6246-d83d-e063-dadaa90ab31fFamily Wellness Athletes Foot Tolnaftate 1% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-991-00Family Wellness Athletes Foot Tolnaftate 1 Cream14 g in 1 TUBECREAM143
55319-991-00Family Wellness Athletes Foot Tolnaftate 1 Cream1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-991FAMILY WELLNESS ATHLETES FOOT TOLNAFTATE 1 CREAM (TOLNAFTATE) CREAM [FAMILY DOLLAR STORES, INC]3Current NDC, 2 package rows20250226_f72b5bcd-8834-4da9-aa74-78992ec2838f.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-99155319-991-00

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
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Athletes Foot Tolnaftate 1 CreamTOLNAFTATEFamily Dollar Stores, Incf72b5bcd-8834-4da9-aa74-78992ec2838f2025-02-25WarningsExact identifier
ndc (package): 55319-991-00
ndc (product): 55319-991
ndc11 (package): 55319099100
spl id: 2ef25f71-76b2-a7ef-e063-6294a90a48b4
spl set id: f72b5bcd-8834-4da9-aa74-78992ec2838f

Reported adverse events (FAERS/openFDA)#

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