FDA.reportPublic FDA data

FifthPulse Clotrimazole Cream 1oz

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 1oz
Active ingredientCLOTICASONE
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69571-018-01FifthPulse Clotrimazole Cream 1oz28.4 g in 1 TUBECREAM28.41

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
69571-01869571-018-01

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
PETROLATUM4T6H12BN9UIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CLOTICASONE6CN32ZUQ4XACTIB
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT

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
3a3858d8-5106-8f2f-e063-6394a90a7a5a3a3858d8-5105-8f2f-e063-6394a90a7a5a2025-07-18WarningsExact identifier
spl id: 3a3858d8-5106-8f2f-e063-6394a90a7a5a
spl set id: 3a3858d8-5105-8f2f-e063-6394a90a7a5a

Reported adverse events (FAERS/openFDA)#

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