FDA.reportPublic FDA data

Clotrimazole Cream-Antifungal

Manufacturer
Rite Aid Corporation | Encube Ethicals Private Limited
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 20:40:05

Label at a glance#

ProductFoot Care Clotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

cures most athlete’s foot, jock itch, and ringworm  relieves itching, burning, cracking, scaling, and discomfort

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, USP 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

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 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 (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
  • 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

SPL UNCLASSIFIED SECTION

  • Store at room temperature 20°-25°C (68°-77°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 -833-285-4151 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Lotrimin® AF Athlete's Foot Cream*

Athlete's Foot Cream

Clotrimazole Cream, USP 1%

ANTIFUNGAL

cures most athlete's foot

relieves itching and burning

NET WT. 0.5 OZ (14 g)

FOR EXTERNAL USE ONLY

*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole, USP 1%
Clotrimazole, USP 1%

RITE AID Athlete's Foot Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0350FOOT CARE CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [RITE AID CORPORATION]12Legacy NDC20250402_d77a46d5-e990-43c4-a591-96d37eb849ac.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H654
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H654
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S4
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GU4
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RN4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X4
WATERINACTIVE INGREDIENT059QF0KO0R4

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
11822-035011822-0350-3

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 · 133 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 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
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNCREAM / TOPICAL10 mgExact identifier — unii candidate
36 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YGEL / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR30 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / ORAL10.06 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRASYNOVIAL13 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSOLUTION / TOPICALNAExact 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
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVITREAL0.86 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR15.55 mgExact identifier — unii candidate
36 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET, FILM COATED / ORAL0.11 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YFILM / TRANSDERMAL32.44 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SOLUTION / INTRAVENOUS27 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVENOUS120 mgExact identifier — unii candidate
36 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSYSTEM / TRANSDERMAL4.05 mgExact identifier — unii candidate
9 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVASCULAR0.15 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNLOTION, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
36 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / ORAL1500 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION/ DROPS / OPHTHALMIC8 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRAMUSCULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / VAGINAL3 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRA-ARTICULAR14 mgExact identifier — unii candidate
36 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUSUPPOSITORY / VAGINALNAExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSYRUP / ORAL20.6 mg/5mlExact identifier — unii candidate
36 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
76e4adc0-26a2-4152-b3f8-b8eb8ee9c2acd77a46d5-e990-43c4-a591-96d37eb849ac2025-09-09WarningsExact identifier
spl set id: d77a46d5-e990-43c4-a591-96d37eb849ac

Reported adverse events (FAERS/openFDA)#

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