FDA.reportPublic FDA data

Clotrimazole Cream USP,1% Antifungal Cream

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:02

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching scaling cracking burning redness soreness irritation discomfort

Dosage and administration

This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. clean 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;...

Storage and handling

To open: unscrew cap, use the pointed end of cap to puncture seal. store between 2°- 30°C (36° - 86°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 athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of
  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort

Warnings

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use

  • on children under 2 years of age

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean 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; change shoes and socks at least once daily

Other information

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 2°- 30°C (36° - 86°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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 15 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2317-52025-01-30C16284748780-12cef2736-88e1-d83d-e063-dadaa90ab31fClotrimazole Cream USP,1% Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2317-5Clotrimazole1 in 1 CARTONCREAM12
68071-2317-5Clotrimazole30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2317CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20220115_b69db78b-5f10-8ca2-e053-2a95a90ac88c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2002-1GM - Gram51672-20024c2e5eee-4d44-4728-9055-74c57d45325912012-07-24
51672-2002-2GM - Gram51672-200288f9179a-bac8-4b62-817d-35adddf30d7012012-07-24

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-231768071-2317-5
51672-2002

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.a3a5cbf5-cabb-48d8-8877-74a97f7c0f572025-07-03WarningsExact identifier
ndc (product): 51672-2002
d58ed27c-5ff8-3a1f-e053-2a95a90a17e5b69db78b-5f10-8ca2-e053-2a95a90ac88c2022-01-14WarningsExact identifier
spl id: d58ed27c-5ff8-3a1f-e053-2a95a90a17e5
spl set id: b69db78b-5f10-8ca2-e053-2a95a90ac88c

Reported adverse events (FAERS/openFDA)#

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