Clotrimazole Cream-Antifungal

Manufacturer
Actavis Pharma, Inc.
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:32:07

Label at a glance#

ProductClotrimazole Antifungal
Active ingredientCLOTRIMAZOLE
Label structure13 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 joc...

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, 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 last longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information

SPL UNCLASSIFIED SECTION

• Store between 2o-30oC (36o – 86oF).  • 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

Actavis
NDC 0472-0350-56
Compare to the active ingredient in Lotrimin® AF*  

Clotrimazole Cream, USP 1%
Antifungal
Cures Most Athlete’s Foot
Relieves: Itching │ Burning │ Cracking │ Scaling 

Net wt. 1 oz (28 g)

Clotrimazole Cream
Clotrimazole Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0350-56GM - Gram0472-03507c94e654-58a1-431d-9a42-7292cddc990412017-03-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0472-03500472-0350-56

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 · 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
42b09e28-65ef-408d-bf7a-db7e22b1c71fe03d9368-e1b4-4e37-87e4-3ee241916aed2021-10-19WarningsExact identifier
spl id: 42b09e28-65ef-408d-bf7a-db7e22b1c71f
spl set id: e03d9368-e1b4-4e37-87e4-3ee241916aed

Reported adverse events (FAERS/openFDA)#

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