FDA.reportPublic FDA data

Clotrimazole Cream USP,1% Antifungal Cream

Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:04:57

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Clotrimazole

GENERIC: Clotrimazole

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-3396-0

COLOR: white

PACKAGING: 15 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Clotrimazole 1g in 100g

INACTIVE INGREDIENT(S):

  • benzyl alcohol
  • cetostearyl alcohol
  • cetyl esters wax
  • polysorbate 60
  • water
  • sorbitan monostearate

Remedy_LabelRemedy_Label

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
70518-339670518-3396-0
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
079a20da-3e02-7dc9-e063-6294a90a3084574236a0-2943-43e1-86ea-b800d758c3012023-10-13WarningsExact identifier
spl set id: 574236a0-2943-43e1-86ea-b800d758c301

Reported adverse events (FAERS/openFDA)#

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