Clotrimazole Cream, 1%

Manufacturer
Estiva Generics Corporation
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:38:57

Label at a glance#

ProductClotrimazole Cream, 1%
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Indications and uses

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

Dosage and administration

Wash the 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 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 i...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only. 
  • Do not use onchildren under 2 years of age unless directed by a doctor. 
  • When using this productavoid contact with eyes. 
  • Stop use and ask a doctor if 
  • Irritation occurs 
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). 
  • 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the 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 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 condition 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cetyl Esters, Curcuma Longa (Turmeric)
Root Extract, Ethylhexyl Palmitate, Ethylhexylglycerin, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Sorbitan Stearate,Tocopheryl Acetate, Triethanolamine, Water (Aqua)

SPL UNCLASSIFIED SECTION

Questions?844-966-7265

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85633-004CLOTRIMAZOLE CREAM, 1% (CLOTRIMAZOLE) CREAM [ESTIVA GENERICS CORPORATION]1Unmatched20250520_4200b518-eaa9-47f7-babc-793fd54cbde1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85633-004-01GM - Gram85633-0042e0c6776-20d9-4215-bbec-5dc1fda2649912025-09-12

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85633-00485633-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4cadf5a9-200d-7281-e063-6294a90a1b704200b518-eaa9-47f7-babc-793fd54cbde12026-03-10WarningsExact identifier
spl set id: 4200b518-eaa9-47f7-babc-793fd54cbde1

Reported adverse events (FAERS/openFDA)#

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