FDA.reportPublic FDA data

FifthPulse clotrimazole cream 4oz

Manufacturer
Front Pharmaceutical PLC
Effective date
2025-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:25

Label at a glance#

ProductFifthPulse clotrimazole cream 4oz
Active ingredientCLOTRIMAZOLE
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DOSAGEDOSAGE

WARNINGS SECTION

warningwarning

INACTIVE INGREDIENT SECTION

inactive ingredientinactive ingredient

INDICATIONS & USAGE SECTION

IndicationIndication

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

OTC - PURPOSE SECTION

purposepurpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABELPACKAGE LABEL

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
69571-019-01FifthPulse clotrimazole cream 4oz113.4 g in 1 TUBECREAM113.41

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69571-01969571-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PETROLATUM4T6H12BN9UIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT

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
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
ndc (package): 69571-019-01
ndc (product): 69571-019
ndc11 (package): 69571001901
spl id: 3a389093-48f3-29cb-e063-6294a90ada37
spl set id: 3a389093-48f2-29cb-e063-6294a90ada37

Reported adverse events (FAERS/openFDA)#

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