FDA.reportPublic FDA data

FifthPulse Miconazole Nitrate 2% Antifungal Cream

Manufacturer
WeCare Products LLC
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:27

Label at a glance#

ProductFifthPulse Miconazole Nitrate Antifungal
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

Proven clinically effective in the treatment of most athlete's foot (tinea pedis) , jock itch (tinea cruris), and ringworm (tinea corporis) Relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Dosage and administration

• Clean the affected area and dry thoroughly.• Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. • Supervise children in the use of this product. • For athelete's foot:Pay special attention to the spaces between the toes; • Wear well-fitting ventilated shoes • Change socks at least once daily. For ringworm: Use daily for 4 weeks. If condition persists...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) , jock itch (tinea cruris), and ringworm (tinea corporis)
  • Relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Warnings

WARNINGS SECTION

For external use only.

Do not use 

OTC - DO NOT USE SECTION

if the safety-sealed tube is punctured or damaged.

Do not useon children 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
  • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Clean the affected area and dry thoroughly.• Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. • Supervise children in the use of this product. • For athelete's foot:Pay special attention to the spaces between the toes; • Wear well-fitting ventilated shoes • Change socks at least once daily.
For ringworm:Use daily for 4 weeks. If condition persists, consult a doctor.
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.

Other information:

SPL UNCLASSIFIED SECTION

• Store at 15° to 30° C (59° to 86°F) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Carbomer, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and-di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water, Stearic acid, Triethanolamine.

Questions or Comments?

OTC - QUESTIONS SECTION

Please call 1-888-209-5201

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package7Outer Package7Inner Package7Inner Package7

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package8Outer Package8Inner Package8Inner Package8

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840331605280GTIN-13: 0840331605280
EAN-13: 0840331605280
GTIN-12: 840331605280
UPC-A: 840331605280
GTIN storage (14 digits): 00840331605280		Outer Package7.jpg
BarcodeEAN-130840331605297GTIN-13: 0840331605297
EAN-13: 0840331605297
GTIN-12: 840331605297
UPC-A: 840331605297
GTIN storage (14 digits): 00840331605297		Outer Package8.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87525-004-01FifthPulse Miconazole Nitrate Antifungal1 in 1 BOXOINTMENT11
87525-004-01FifthPulse Miconazole Nitrate Antifungal28.4 g in 1 TUBEOINTMENT28.41
87525-004-02FifthPulse Miconazole Nitrate Antifungal1 in 1 BOXOINTMENT11
87525-004-02FifthPulse Miconazole Nitrate Antifungal113.4 g in 1 TUBEOINTMENT113.41

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87525-00487525-004-01, 87525-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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 Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
ndc (package): 87525-004-01
ndc (package): 87525-004-02
ndc (product): 87525-004
ndc11 (package): 87525000401
ndc11 (package): 87525000402
spl id: 4e7d2ee6-0c87-7391-e063-6394a90a4ee8
spl set id: b70238eb-afcb-4e09-976f-973df249241c

Reported adverse events (FAERS/openFDA)#

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