FDA.reportPublic FDA data

Clotrimazole

Manufacturer
OL PHARMA TECH,LLC | OL PHARMA TECH,LLC (Drs, pharmacy)
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:13

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure13 sections

Indications and uses

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

Dosage and administration

wash the affected area and dry thoroughly apply a thin layer of the 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 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 jo...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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 which accompany these conditions

warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask your doctor if:

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • wash the affected area and dry thoroughly
  • apply a thin layer of the 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 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 lasts longer, contact a doctor

  • this product is not effective on the scalp or nails

Other information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information

Inactive ingredients

INACTIVE INGREDIENT SECTION

sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

original strenghth

Antifungal cream

clotrimazoleclotrimazole

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN4
309367clotrimazole 10 MG/ML Topical CreamSCD4
309367clotrimazole 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80489-002-012023-01-17C16284748780-1d6a99b39-4d82-a426-e053-dadaa90af4c2b0e9fc77-6d5c-2472-e053-2995a90a3de4
80489-002-012022-01-28C16284748780-1d6a99b39-4d82-a426-e053-dadaa90af4c2b0e9fc77-6d5c-2472-e053-2995a90a3de4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-002-01Clotrimazole1 in 1 CARTONCREAM14
80489-002-01Clotrimazole28.3 g in 1 TUBECREAM28.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-002CLOTRIMAZOLE (DRS. CLOTRIMAZOLE) CREAM [OL PHARMA TECH,LLC]4Current NDC, Legacy NDC, 2 package rows20250112_b0e9fc77-6d5c-2472-e053-2995a90a3de4.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-00280489-002-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
CETEARETH-127V4MR24V5PIACT
METHYLPARABENA2I8C7HI9TIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
MINERAL OILT5L8T28FGPIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
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
ClotrimazoleDRS. CLOTRIMAZOLEOL PHARMA TECH,LLCb0e9fc77-6d5c-2472-e053-2995a90a3de42025-01-09WarningsExact identifier
ndc (package): 80489-002-01
ndc (product): 80489-002
ndc11 (package): 80489000201
spl id: 2b522583-1d23-f3bb-e063-6394a90a76a7
spl set id: b0e9fc77-6d5c-2472-e053-2995a90a3de4

Reported adverse events (FAERS/openFDA)#

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