Clotrimazole 1% Topical Antifungal Cream

Manufacturer
Mohnark Pharmaceuticals Inc.
Effective date
2025-07-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:08:03

Label at a glance#

ProductClotrimazole 1% Topical Antifungal Cream
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night). Children under 2 years of age: consult a doctor

Dosage and administration

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) 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 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 l...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

PURPOSE

OTC - PURPOSE SECTION

Antifungal

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 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 2 weeks (for jock itch)

Keep out of reach of children.

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

STOP USE AND ASK DOCTOR IF

OTC - ASK DOCTOR SECTION

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

DIRECTIONS

OTC - WHEN USING SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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 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, ask a doctor
  • this product is not effective on the scalp or nails

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • To open: unscrew cap, remove liner seal and replace cap
  • Store at USP controlled room temperature 20-25°C (68-77°F)
  • see carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

10 milligrams/gram per application

DOSAGE AND ADMINISTRATION

RECENT MAJOR CHANGES SECTION

added dosage information

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).
Children under 2 years of age: consult a doctor

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole 1% CartonClotrimazole 1% Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN6
309367clotrimazole 10 MG/ML Topical CreamSCD6
309367clotrimazole 1 % Topical CreamSY6

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
73715-004-01Clotrimazole 1% Topical Antifungal Cream28 g in 1 TUBECREAM286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73715-004-01GM - Gram73715-004ad2e9ab2-7e49-4d0d-b82e-48100e2edd8c12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73715-00473715-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3a5f968f-49fe-22e3-e063-6294a90a57e4b3b83f3f-9349-fb75-e053-2995a90acb652025-07-20WarningsExact identifier
spl id: 3a5f968f-49fe-22e3-e063-6294a90a57e4
spl set id: b3b83f3f-9349-fb75-e053-2995a90acb65

Reported adverse events (FAERS/openFDA)#

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