TM-Clotrimazole

Manufacturer
Singular Dreamer, Ltd dba True Marker
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:38:12

Label at a glance#

ProductTM-Clotrimazole
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 itch,...

Label contents#

Full prescribing information#

Active ingredients

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 – On children under 2 years of age unless directed by a doctor.
  • When using this product, avoid 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 out of 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

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides,Petrolatum, Polyoxyethylene lauryl ether, Purified water.

Questions?

SPL UNCLASSIFIED SECTION

304-742-2433

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83035-1062-3TM-Clotrimazole1 in 1 CARTONCREAM14
83035-1062-3TM-Clotrimazole30 g in 1 TUBECREAM304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83035-1062-3GM - Gram83035-1062e752177f-dbeb-4d2d-a247-0ac7d03d267b12023-05-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-106283035-1062-3

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-07full-release2026-06-01 00:25:57

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
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
ndc (package): 83035-1062-3
ndc (product): 83035-1062
ndc11 (package): 83035106203
spl id: 407e8bf6-8d07-2136-e063-6294a90a1772
spl set id: d6a9755a-9ed1-4e7d-8e73-25c169d6c6b1

Reported adverse events (FAERS/openFDA)#

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