FDA.reportPublic FDA data

Clotrimazole Cream, USP

Manufacturer
Rite Aid Corporation
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
monthly-update
Hydrated at
2026-06-03 17:46:52

Label at a glance#

ProductAntifungal
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole, USP 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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 a doctor if

OTC - STOP USE SECTION

  • irritation occurs   •
  • there is no improvement within 2 weeks

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 (1-800-222-1222) 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
  • use daily for 2 weeks
  •  if condition lasts longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

OTHER SAFETY INFORMATION

  • Store between 2°-30°C (36°-86°F). 
  • Before using any medication, read all label directions. Keep carton, it contains important information

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Lotrimin® AF Jock Itch Cream*

Jock Itch Cream

Clotrimazole Cream, USP 1%

ANTIFUNGAL

cures most jock itch

relieves itching, burning, scaling and chafing

FOR EXTERNAL USE ONLY

NET WT OZ (g)

*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Jock Itch Cream.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID Jock Itch Cream Antifungal
RITE AID Jock Itch Cream Antifungal

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
11822-0351-32023-02-20C16284748780-1f386c649-d8d6-0266-e053-dadaa90a7c1aClotrimazole Cream, USP
11822-0351-32023-01-30C16284748780-1f386c649-d8d6-0266-e053-dadaa90a7c1aClotrimazole Cream, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H653
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H653
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GU3
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO283
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RN3
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-035111822-0351-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 124 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAMUSCULAR120 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUPPOSITORY / VAGINALNAExact identifier — unii candidate
11 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / TOPICAL0.46 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRASYNOVIAL13 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNLOTION / TOPICAL8 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRA-ARTICULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15.55 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRA-ARTICULAR14 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XLOTION / TOPICAL89 mgExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GULOTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRALESIONAL14 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.61 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRAMUSCULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVENOUS120 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates

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
cbc3f22f-089f-4dd2-9637-6693d5bb4f135ee757e9-83eb-4829-838b-0db8fd5caa202025-12-29WarningsExact identifier
spl id: cbc3f22f-089f-4dd2-9637-6693d5bb4f13
spl set id: 5ee757e9-83eb-4829-838b-0db8fd5caa20

Reported adverse events (FAERS/openFDA)#

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