FDA.reportPublic FDA data

Clotrimazole Cream

Manufacturer
Galentic Pharma (India) Private Limited
Effective date
2024-10-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:50:58

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Indications and uses

cures most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling and discomfort

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°C 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

Active Ingredient

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

• USES

INDICATIONS & USAGE SECTION

  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort

• WARNINGS

WARNINGS SECTION

For external use only

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 ask doctor if

OTC - STOP USE SECTION

  • 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

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

• INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Ceteareth 20, cetostearyl Alcohol, Methylparaben, Mineral oil, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

SPL UNCLASSIFIED SECTION

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

Gandhidham-370 230, Gujarat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Galentic

Clotrimazole Cream

Antifungal cream

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

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 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50382-02550382-025-13

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
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
WATER059QF0KO0RIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
255cf467-5fab-a262-e063-6394a90aacd06c09bb74-150d-4823-85c2-ba451c1c29ff2024-10-26WarningsExact identifier
spl id: 255cf467-5fab-a262-e063-6394a90aacd0
spl set id: 6c09bb74-150d-4823-85c2-ba451c1c29ff

Reported adverse events (FAERS/openFDA)#

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