1MED Clotrimazole 1% Antifungal Cream

Manufacturer
QYK BRANDS LLC | QYK
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:05

Label at a glance#

Product1MED Clotrimazole 1% Antifungal Cream
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

OTC - PURPOSE SECTION

Antifungal

cures most athlete's foot, jock itch and ringworm

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

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

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

INSTRUCTIONS FOR USE SECTION

wash 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 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, ask a doctor
this product is not effective on the scalp or nails

DOSAGE & ADMINISTRATION SECTION

10 milligrams/gram per application

INACTIVE INGREDIENT SECTION

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

OTHER SAFETY INFORMATION

To open: unscrew cap, remove liner seal and replace cap
Store at USP controlled room temperature 20-25°C (68-77°F)
see carton or tube crimp for lot number and expiration date

INDICATIONS & USAGE SECTION

Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).
Children under 2 years of age: consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73750-091-052023-07-28C16284748780-10191ceaa-6226-198a-e063-dbdaa90aec3eHUMAN OTC DRUG LABEL
73750-091-102023-07-28C16284748780-10191ceaa-6226-198a-e063-dbdaa90aec3eHUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73750-091-051MED Clotrimazole 1% Antifungal Cream15 g in 1 TUBECREAM152
73750-091-101MED Clotrimazole 1% Antifungal Cream30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73750-0911MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM (CLOTRIMAZOLE 1% ANTIFUNGAL CREAM) CREAM [QYK BRANDS LLC]2Legacy NDC, 2 package rows20220205_d7183409-f6ff-4915-e053-2a95a90a0979.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73750-091-05GM - Gram73750-091ae11b1d7-e245-48ee-8b09-b0ebc5938c5612022-06-06
73750-091-10GM - Gram73750-091a296d895-ad5f-4b03-a5e8-95e10ecdea5b12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73750-09173750-091-10, 73750-091-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
d736edf7-a371-5c85-e053-2a95a90aa7dfd7183409-f6ff-4915-e053-2a95a90a09792022-02-04WarningsExact identifier
spl id: d736edf7-a371-5c85-e053-2a95a90aa7df
spl set id: d7183409-f6ff-4915-e053-2a95a90a0979

Reported adverse events (FAERS/openFDA)#

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