FDA.reportPublic FDA data

Perrigo Clotrimazole Cream USP, 1% Drug Facts

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:06:23

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 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)   Relabeled By: Preferred Pharmaceuticals Inc.

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)
  • Relabeled By: Preferred Pharmaceuticals Inc.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cures Most Athlete’s Foot

Relieves Itching & Burning

Greaseless, Non-Staining

Compare to Lotrimin® AF active ingredient

Clotrimazole Cream USP, 1%

Antifungal

NET WT 0.5 OZ (15 g)

Repackaged By: Preferred Pharmaceuticals Inc.

NDC 68788-7402-2

Clotrimazole Cream USP, 1%
Clotrimazole Cream USP, 1%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7402-2GM - Gram68788-740251bd23eb-7d12-4044-9eaf-2a2865d12cf712024-04-05
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
68788-740268788-7402-2
45802-434

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
CLOTRIMAZOLEG07GZ97H65ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT

Source Document#

Source XML · Source PDF

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
e77c83c8-f47d-4589-8ab2-553a9db2523fdbe65736-86d4-4585-aebd-2546fdfb78822025-03-07WarningsExact identifier
spl set id: dbe65736-86d4-4585-aebd-2546fdfb7882

Reported adverse events (FAERS/openFDA)#

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