Clotrimazole Topical Solution 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 00:48:13

Label at a glance#

ProductCLOTRIMAZOLE
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

• Cures most athlete's foot, jock itch and ringworm infections • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

• Wash affected area and dry thoroughly • Apply to the affected area twice daily (morning and night) or as directed by your 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 • if condition persists lon...

Storage and handling

Store at room temperature (68 ° to 77 ° F) Retain this carton for future reference

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 infections

• 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 eyes. If contact occurs rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks 

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 affected area and dry thoroughly

• Apply to the affected area twice daily (morning and night) or as directed by your 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

• if condition persists longer, consult your doctor

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Polyethylene Glycol

Other Information:

STORAGE AND HANDLING SECTION

Store at room temperature (68° to 77°F)

Retain this carton for future reference

Questions or Comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

  • Relieves itching & burning
  • Greaseless
  • Non-Staining

*Compare to the active ingredient in Lotrimin®AF

All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin®AF

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
72570-110-302023-03-16C16284748780-19d75b9d1-144c-f424-e053-dadaa90a57ceClotrimazole Topical Solution USP 1%
72570-110-302020-01-31C16284748780-19d75b9d1-144c-f424-e053-dadaa90a57ceClotrimazole Topical Solution USP 1%

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-11072570-110-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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
0889b94a-6757-4acf-80d6-1d4dd36a5f69762a93d9-e808-470c-a939-02751f3bded92023-03-15WarningsExact identifier
spl set id: 762a93d9-e808-470c-a939-02751f3bded9

Reported adverse events (FAERS/openFDA)#

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