Clotrimazole Cream USP, 1% Drug Facts

Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:53:00

Label at a glance#

Productclotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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 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 •...

Storage and handling

• store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 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 which accompany these conditions

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 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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 persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

HOW SUPPLIED

How Supplied Section

Clotrimazole 1% Cream

NDC 72162-2340-3: 30 g in a TUBE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole 1% Cream #30

Label
Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2340CLOTRIMAZOLE CREAM [BRYANT RANCH PREPACK]3Unmatched20241011_78fd5ceb-9154-4704-9c53-01f90226ef2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2340-3GM - Gram72162-23405b3863e3-b92c-4225-9599-bbadcbda5b3912024-07-12
45802-434-01GM - Gram45802-434d14ca4ba-e10d-4e66-9753-635847aed1a612012-07-24
45802-434-11GM - Gram45802-434a0b1e4f4-5f17-41be-ab4f-f972953bca2e12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72162-234072162-2340-3
45802-434

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
clotrimazoleCLOTRIMAZOLEPadagis Israel Pharmaceuticals Ltd3dcd0158-ec51-4fa7-a26a-02c2926156c02026-01-22WarningsExact identifier
ndc (product): 45802-434
78fd5ceb-9154-4704-9c53-01f90226ef2e78fd5ceb-9154-4704-9c53-01f90226ef2e2024-10-03WarningsExact identifier
spl id: 78fd5ceb-9154-4704-9c53-01f90226ef2e
spl set id: 78fd5ceb-9154-4704-9c53-01f90226ef2e

Reported adverse events (FAERS/openFDA)#

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