FDA.reportPublic FDA data

Tinactin

Manufacturer
Delpharm Montreal Inc.
Effective date
2020-07-24
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 23:19:43

Label at a glance#

ProductTinactin
Active ingredientTOLNAFTATE
Label structure11 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 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 use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twi...

Storage and handling

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

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 - 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, 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 information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-866-360-3266

SPL UNCLASSIFIED SECTION

Distributed by Bayer HealthCare LLC Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinactin ®

ANTIFUNGAL

tolnaftate

CREAM

Relieves:

  • itching
  • burning

NET WT

30g (1 oz)

Tinactin 1190Tinactin 1190

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
69213-119069213-1190-1, 69213-1190-2

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
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
PETROLATUM4T6H12BN9UIACT
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
abab0d8f-a09b-8463-e053-2995a90a99704e3e319c-f085-734d-e054-00144ff88e882020-07-24WarningsExact identifier
spl id: abab0d8f-a09b-8463-e053-2995a90a9970
spl set id: 4e3e319c-f085-734d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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