Clotrimazole Topical Solution USP,1%

Manufacturer
The Podiatree Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:06

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most athlete's foot infections and ringworm infections relieve itching,burning, cracking, scaling and discomfort which can 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily • for athlete’s foot and ringworm infections, use daily for 4 weeks • if condition pers...

Storage and handling

Store at 20° to 25°C (68° to 77°F)

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 infections and ringworm infections
  • relieve itching,burning, cracking, scaling and discomfort which can 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.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

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

• 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily

• for athlete’s foot and ringworm infections, 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 20° to 25°C (68° to 77°F)

Questions?

OTC - QUESTIONS SECTION

1-855-763-8733

SPL UNCLASSIFIED SECTION

Manufactured for

The Podiatree Company, Holbrook, NY 11741

Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 30 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

artworkartwork


DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130040232289910GTIN-13: 0040232289910
EAN-13: 0040232289910
GTIN-12: 040232289910
UPC-A: 040232289910
GTIN storage (14 digits): 00040232289910
ClotrimPEG30ml box artwork.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-018-30Clotrimazole30 mL in 1 BOTTLESOLUTION302
54633-018-30Clotrimazole1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54633-018-10ML - Milliliter54633-0185d270aba-d4aa-4705-94da-d987f30625b012018-05-09
54633-018-30ML - Milliliter54633-0187a2e56cc-6dfd-4b36-8619-014b55ca614112018-12-13

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
54633-01854633-018-30

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
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
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company68a4e3f5-f84d-5650-e053-2a91aa0a171d2026-01-08WarningsExact identifier
ndc (product): 54633-018
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company79234400-0766-792c-e053-2a91aa0a6e6d2026-01-08WarningsExact identifier
ndc (package): 54633-018-30
ndc (product): 54633-018
ndc11 (package): 54633001830
spl id: 47e3501c-5ccb-b8af-e063-6294a90a9c4c
spl set id: 79234400-0766-792c-e053-2a91aa0a6e6d

Reported adverse events (FAERS/openFDA)#

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