CLOTRIMAZOLE

Manufacturer
ALLIED TRADE LINK LLC | GOLPALDAS VISRAM AND COMPANY LIMITED
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:01

Label at a glance#

ProductCLOTRIMAZOLE
Active ingredientCLOTRIMAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE AND ADMISITRATION

DOSAGE & ADMINISTRATION SECTION

Clotrimazole 1% ..

Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 persists longer, consult a doctor. This product is not effective on the scalp or nails

Warnings

WARNINGS AND PRECAUTIONS SECTION

For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete’s foot or ringworm

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Methylparaben, Mineral Oil, Macrogol cetostearyl ether, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

INDICATIONS & USAGE SECTION

For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch and itching or burning feet

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.

OTC - PURPOSE SECTION

Antifungal

WARNINGS SECTION

For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete’s foot or ringworm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clotrimazoleclotrimazole

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

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
84387-004-01CLOTRIMAZOLE28.4 g in 1 TUBECREAM28.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84387-004CLOTRIMAZOLE CREAM [ALLIED TRADE LINK LLC]1Current NDC, 1 package rows20241115_266d7b94-2954-4831-e063-6394a90a3f33.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84387-00484387-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
ndc (package): 84387-004-01
ndc (product): 84387-004
ndc11 (package): 84387000401
spl id: 266d7b94-2955-4831-e063-6394a90a3f33
spl set id: 266d7b94-2954-4831-e063-6394a90a3f33

Reported adverse events (FAERS/openFDA)#

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