FDA.reportPublic FDA data

Athletes Foot

Manufacturer
The IBN SINA Pharmaceutical Industry Ltd.
Effective date
2019-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:47

Label at a glance#

ProductAthletes Foot
Active ingredientCLOTRIMAZOLE
Label structure15 sections

Storage and handling

Other information store at 2° - 30° C (36° - 86° F) Lot No. & Exp. Date: see box or see crimp of tube

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Clotrimazole 1%

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor

OTC - WHEN USING SECTION

When using this product avoid contact with the 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 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • wash the 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
  • for athlete's foot:
  • pay special attention to the spaces between the toes
  • wear well-fitting ventilated shoes
  • 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 persists longer, consult a doctor
  • this product is not effective on the scalp or nails

STORAGE AND HANDLING SECTION

Other information

  • store at 2° - 30° C (36° - 86° F)
  • Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ingredients

cetostearyl alcohol, methylparaben, mineral oil, paraffin, polyoxyl 40 hydrogenated castor oil, polysorbate 80, water

OTC - QUESTIONS SECTION

Questions?

Call 1-833-IBN-SINA (1-833-426-7462)

SPL UNCLASSIFIED SECTION

Manufactured by:

The IBN SINA Pharmaceutical Industry Ltd.

Holding # A-80, Ward # 9, Shafipur, Kaliakoir

Gazipur-1751 Bangladesh

www.ibnsinapharma.com

Product of Bangladesh

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72103-527-10

Athlete's Foot!

Clotrimazole Cream, USP 1%

Antifungal Cream

Net Wt. 0.35 oz (10g)

Cures Most Athlete's Foot

ATHLETES FOOTATHLETES FOOT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

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
72103-527-102021-01-29C16284748780-1ba0f9c33-3a7a-a910-e053-dadaa90a0b85Athlete's Foot

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72103-527-10Athletes Foot10 g in 1 TUBECREAM101
72103-527-10Athletes Foot1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72103-527ATHLETES FOOT (CLOTRIMAZOLE) CREAM [THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.]1Legacy NDC, 2 package rows20190315_841234c0-883b-5ea9-e053-2991aa0abdaf.zip

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
72103-52772103-527-10

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
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
POLYSORBATE 806OZP39ZG8HIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT

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
841234c0-883c-5ea9-e053-2991aa0abdaf841234c0-883b-5ea9-e053-2991aa0abdaf2019-03-14WarningsExact identifier
spl id: 841234c0-883c-5ea9-e053-2991aa0abdaf
spl set id: 841234c0-883b-5ea9-e053-2991aa0abdaf

Reported adverse events (FAERS/openFDA)#

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