FDA.reportPublic FDA data

Major Clotrimazole

Manufacturer
Proficient Rx LP
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:12:09

Label at a glance#

ProductMajor Clotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage and administration

• Clean the affected area and dry thoroughly. • Apply a thin layer of this product 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 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal Cream

Uses

INDICATIONS & USAGE SECTION

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product 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 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 4 weeks. For jock itch, use daily for 2 weeks.
  • If conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA

Relabeled By Proficient Rx LP
Thousand Oaks, CA 91320


Re-Oder No. 100431

Principal Display Panel – ½ oz. Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-438-05

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

Cures Most Athlete's Foot NET WT. 14.17 g (1/2oz)

71205-438-05
71205-438-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-438MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [PROFICIENT RX LP]3Legacy NDC20240131_93f884c0-76d9-4df4-9eef-b904cfddac49.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7822-31GM - Gram0904-78224550ddd1-4c27-45ac-a609-7e213f99b25212013-08-02
0904-7822-36GM - Gram0904-7822fbe6bade-1447-4324-b21c-27f87754c0b212013-08-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-43871205-438-05
0904-7822

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
CLOTRIMAZOLEG07GZ97H65ACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
BENZYL ALCOHOLLKG8494WBHIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTYLDODECANOL461N1O614YIACT
CETYL PALMITATE5ZA2S6B08XIACT

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
9035bcb7-a6e2-405f-b1c0-35f24cb1af2f93f884c0-76d9-4df4-9eef-b904cfddac492026-04-01WarningsExact identifier
spl set id: 93f884c0-76d9-4df4-9eef-b904cfddac49

Reported adverse events (FAERS/openFDA)#

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