FDA.reportPublic FDA data

Tolnaftate Cream

Manufacturer
Galentic Pharma (India) Private Limited
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:50:32

Label at a glance#

ProductTolnaftate
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

Proven clinically effective in the treatment of most athlete's foor (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) 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) or as directed by a doctor 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 for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for ...

Storage and handling

store between 15° to 30°C (59° to 86°F) Lot No. & Exp. Date: See box or crimp of tube

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 most athlete's foor (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • 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 eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on children 2 years of age unless directed by a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

• DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • 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
  • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • If condition persists longer consult a doctor
  • this product is not effective on the scalp or nails

• OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store between 15° to 30°C (59° to 86°F)
  • Lot No. & Exp. Date: See box or crimp of tube

• INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Ceteth 20, Cetyl alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Sorbitan Monostearate, Stearyl Alcohol, Purified Water

SPL UNCLASSIFIED SECTION

Manufactured by:

Galentic Pharma (India) Pvt. Ltd.,

Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

Gandhidham - 370230,

Gujarat, India

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Galentic

Antifungal Cream

For treatment of athlete's foot, jock itch, and ringworm

Tolnaftate Cream

NET WT. 1 OZ (28 g)

principal display panel.jpgprincipal display panel.jpg

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
50382-01450382-014-12, 50382-014-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
CETETH-20I835H2IHHXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
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
26159e3c-607e-be27-e063-6394a90ac687e45cf99e-7c4c-4021-90ca-98ce441e44792024-11-04WarningsExact identifier
spl id: 26159e3c-607e-be27-e063-6394a90ac687
spl set id: e45cf99e-7c4c-4021-90ca-98ce441e4479

Reported adverse events (FAERS/openFDA)#

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