FDA.reportPublic FDA data

Clotrimazole

Manufacturer
Rite Aid Corporation | Sun Pharma Canada Inc.
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:07:18

Label at a glance#

ProductClotrimazole Jock Itch
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most jock itch relieves itching, burning, scaling, chafing and discomfort associated with jock itch

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 use daily for 2 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails

Storage and handling

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. to open: unscrew cap, use the pointed end of cap to puncture seal. store between 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most jock itch
  • relieves itching, burning, scaling, chafing and discomfort associated with jock itch

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 2 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION 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
  • use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

MADE IN CANADA

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clotrimazole-01clotrimazole-01Jock Itch Cream

Clotrimazole Cream, USP 1%

ANTIFUNGAL

NET WT 0.5 OZ (14.2 g)

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
11822-3423-1ClotrimazoleJock Itch14.2 g in 1 TUBECREAM14.26
11822-3423-1ClotrimazoleJock Itch1 in 1 CARTONCREAM16

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-342311822-3423-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
WATER059QF0KO0RIACT
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
Clotrimazole Jock ItchCLOTRIMAZOLERite Aid Corporationc2875c05-eedd-4546-89dd-ed88b3f28abd2025-07-14WarningsExact identifier
ndc (package): 11822-3423-1
ndc (product): 11822-3423
ndc11 (package): 11822342301
spl id: 39e4cdb1-4e47-e6f0-e063-6394a90af1bd
spl set id: c2875c05-eedd-4546-89dd-ed88b3f28abd

Reported adverse events (FAERS/openFDA)#

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