FDA.reportPublic FDA data

Antifungal Cream

Manufacturer
Moore Medical LLC | Safetec of America, Inc.
Effective date
2013-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:41:48

Label at a glance#

ProductAntifungal
Active ingredienttolnaftate
Label structure9 sections

Indications and uses

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). With daily use, helps prevent most athlete's foot and helps keep it from coming back. For relief of itching or chaffing associated with jock itch, itchy, scaly skin between the toes or itching, burning feet.

Dosage and administration

Supervise children in the use of this product 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. For the treatment or prevention of 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. For athlete's foot and r...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

First Aid

Drug Facts

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate (1%)

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • With daily use, helps prevent most athlete's foot and helps keep it from coming back.
  • For relief of itching or chaffing associated with jock itch, itchy, scaly skin between the toes or itching, burning feet.

Warnings

WARNINGS SECTION

For external use only

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.

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 product avoid contact with eyes

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (in the case of athlete's foot or ringworm) or within 2 weeks (in the case of jock itch).

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Supervise children in the use of this product
  • 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.
  • For the treatment or prevention of 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.
  • For athlete's foot and ringworm: Use daily for 2 weeks. If the condition lasts longer, consult a doctor.
  • For jock itch: Use daily for 2 weeks. If the condition lasts longer, consult a doctor.
  • To prevent athlete's foot: Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
  • This product is not effective on the scalp or nails.

Other Information:

SPL UNCLASSIFIED SECTION

  • store at 59-86°F (15-30°C)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

cetyl alcohol, chloroxylenol, glycereth-26, mineral oil, petrolatum, sodium citrate, water.

PRINCIPAL DISPLAY PANEL – 144 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mooremedical
Supporting Health & Care

Reorder No. 82481
UPN# 0-0607415-82481-0

MooreBrand
Antifungal Cream
144 Packets
Each Packet Net. Wt. 0.9gm

Soothes and relieves itching,
chafing and burning associated
with athlete's foot, jock itch or
ringworm

To reorder:
Call: 1-800-234-1464
Fax: 1-800-944-6667
Online:
www.mooremedical.com

PRINCIPAL DISPLAY PANEL – 144 count box
PRINCIPAL DISPLAY PANEL – 144 count box

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
tolnaftateACTIVE INGREDIENT06KB629TKV2
tolnaftateACTIVE MOIETY06KB629TKV2
cetyl alcoholINACTIVE INGREDIENT936JST6JCN2
chloroxylenolINACTIVE INGREDIENT0F32U78V2Q2
glycereth-26INACTIVE INGREDIENTNNE56F2N142
mineral oilINACTIVE INGREDIENTT5L8T28FGP2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55670-60255670-602-01

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
NameUNIIKind
tolnaftate06KB629TKVACTIB
cetyl alcohol936JST6JCNIACT
glycereth-26NNE56F2N14IACT
mineral oilT5L8T28FGPIACT
petrolatum4T6H12BN9UIACT
water059QF0KO0RIACT
sodium citrate1Q73Q2JULRIACT
chloroxylenol0F32U78V2QIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 70 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
chloroxylenolCHLOROXYLENOL0F32U78V2QCREAM / TOPICAL0.15 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
chloroxylenolCHLOROXYLENOL0F32U78V2QSOLUTION / AURICULAR (OTIC)0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates

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
96c3ae70-5fe1-4782-e053-2a95a90a5659b5c24e09-dba0-4dc2-bd48-df34692e34a62019-11-07WarningsExact identifier
spl set id: b5c24e09-dba0-4dc2-bd48-df34692e34a6

Reported adverse events (FAERS/openFDA)#

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