CLOTRIMAZOLE CREAM USP 1%

Manufacturer
Delsam Pharma Llc
Effective date
2018-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:34

Label at a glance#

ProductCLOTRIMAZOLE
Active ingredientCLOTRIMAZOLE
Label structure11 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

• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

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 which accompany these conditions

Warnings

WARNINGS SECTION

For external use only

Do not use on children under 2 years of age unless directed by a doctor

When using this product avoid contact with the eyes 

Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ring worm) 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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water.

Other information

STORAGE AND HANDLING SECTION

• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

• store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

Questions or comments?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

Compared to the active ingredient in Lotrimin AF

ANTIFUNGAL

Cures Most Athlete's Foot

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72570-105-302023-03-16C16284748780-19d75b9d0-e740-f424-e053-dadaa90a57ceCLOTRIMAZOLE CREAM USP 1%
72570-105-302020-01-31C16284748780-19d75b9d0-e740-f424-e053-dadaa90a57ceCLOTRIMAZOLE CREAM USP 1%

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
72570-10572570-105-30

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

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
61daad5f-f0ea-4863-89f8-a996f5736a68becd0353-56a7-4c4c-8b7a-1363ef2eefa52023-03-15WarningsExact identifier
spl set id: becd0353-56a7-4c4c-8b7a-1363ef2eefa5

Reported adverse events (FAERS/openFDA)#

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