Clotrimazole Cream-Antifungal

Manufacturer
Chain Drug Consortium, LLC
Effective date
2024-10-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:53:03

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure9 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 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 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?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN LOTRIMIN® AF*

Clotrimazole Cream, USP 1%
ANTIFUNGAL

Proven Clinically Effective in the Treatment of Most Athlete's Foot
Relieves: Itching ι Burning ι Cracking ι Scaling

NET WT 1 OZ (28g)

Principal Display Panel
Principal Display Panel

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 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-03568016-035-06

Ingredients#

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

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

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
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRAMUSCULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUPPOSITORY / VAGINALNAExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVASCULAR0.15 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / SOFT TISSUE13 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 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, MONOHYDRATE593YOG76RNSUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / OPHTHALMIC0.04 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact 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, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRASYNOVIAL13 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / TOPICAL0.46 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRA-ARTICULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRALESIONAL14 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 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 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 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
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / ORAL1500 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVITREAL0.86 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 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 / ORAL10.06 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 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 ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact 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
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUSUPPOSITORY / VAGINALNAExact identifier — unii candidate
5 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
8b5b9ce2-5f35-4f5d-a6fb-e4cac949f689a93b192d-e6c2-4024-84f5-241bdcd34f9a2024-10-09WarningsExact identifier
spl id: 8b5b9ce2-5f35-4f5d-a6fb-e4cac949f689
spl set id: a93b192d-e6c2-4024-84f5-241bdcd34f9a

Reported adverse events (FAERS/openFDA)#

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