FDA.reportPublic FDA data

First Aid Antifungal Medicated Cream

Manufacturer
First Aid Research Corp. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2022-02-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:29

Label at a glance#

ProductFirst Aid Antifungal Medicated
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) proven effective in the prevention of 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 shoes and change 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/...

Storage and handling

store between 20 to 25°C (68 to 77°F) Lot No & Expiration Date: See box or see crimp

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product 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

OTC - DO NOT USE SECTION

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

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.

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 shoes and change 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 scalps or nails

Other information

STORAGE AND HANDLING SECTION

  • store between 20 to 25°C (68 to 77°F)
  • Lot No & Expiration Date: See box or see crimp

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene,  propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.

SPL UNCLASSIFIED SECTION

Distributed by:

First Aid Research Corp.

Jupiter, Florida, USA 33478

Made in India

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Antifungal Medicated Cream
NET WT  1 OZ (28 g)

labellabel

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
75983-002-022024-01-30C16284748780-1d6a99b39-4d5e-a426-e053-dadaa90af4c2First Aid Antifungal Medicated Cream
75983-002-022022-02-24C16284748780-1d6a99b39-4d5e-a426-e053-dadaa90af4c2First Aid Antifungal Medicated Cream
75983-002-022022-01-28C16284748780-1d6a99b39-4d5e-a426-e053-dadaa90af4c2First Aid Antifungal Medicated Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75983-002-01First Aid Antifungal Medicated28 g in 1 TUBECREAM283
75983-002-02First Aid Antifungal Medicated1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75983-002FIRST AID ANTIFUNGAL MEDICATED (TOLNAFTATE) CREAM [FIRST AID RESEARCH CORP.]3Legacy NDC, 2 package rows20220225_b7ae2f6f-bae3-573a-e053-2a95a90a7fa0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75983-00275983-002-01, 75983-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
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
d8c3138a-cad7-fb0f-e053-2a95a90a4a53b7ae2f6f-bae3-573a-e053-2a95a90a7fa02022-02-24WarningsExact identifier
spl id: d8c3138a-cad7-fb0f-e053-2a95a90a4a53
spl set id: b7ae2f6f-bae3-573a-e053-2a95a90a7fa0

Reported adverse events (FAERS/openFDA)#

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