FDA.reportPublic FDA data

Pharmlitalia Jock Itch Miconazole Nitrate - Rida LLC

Manufacturer
Rida LLC
Effective date
2026-04-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:42:22

Label at a glance#

ProductPharmlitalia Jock Itch Miconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

For the relief of symptoms associated with jock itch (tinea cruris). For effective relief of itching, burning, scaling, discomfort, and chafing associated with jock itch.

Dosage and administration

Adults and children 12 years and over: • Wash affected area and dry thoroughly. • Apply a thin layer over affected area twice daily (morning and night). • Supervise children in use of this product. • Use daily for 2 weeks. • If condition persists longer, ask a doctor. • This product is not effective on the scalp or nails. • Wash hands after each use. • Children under 12 years: ask a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate USP, 2%

Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses

INDICATIONS & USAGE SECTION

  • For the relief of symptoms associated with jock itch (tinea cruris).
  • For effective relief of itching, burning, scaling, discomfort, and chafing associated with jock itch.

Warnings

WARNINGS SECTION

  • For external use only

Do not use

  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

When using this product. avoid contact eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if too much irritation occurs or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:
• Wash affected area and dry thoroughly.
• Apply a thin layer over affected area twice daily (morning and night).
• Supervise children in use of this product.
• Use daily for 2 weeks.
• If condition persists longer, ask a doctor.
• This product is not effective on the scalp or nails.
• Wash hands after each use.
• Children under 12 years: ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Do not use if seal on tube is broken or missing. Store at controlled room temperature 20–25°C (68–77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic Tea Tree Oil, Benzoic Acid, Cetyl Alcohol, Isopropyl Myristate, Polysorbate 60, Oxygenated Olive Oil, Potassium Hydroxide, Propylene Glycol, Purified Water, Stearyl Alcohol.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-03183004-031-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
OLIVE OIL6UYK2W1W1EIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-26full-release2026-06-01 01:54:29

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
5088c3e5-35c8-005f-e063-6394a90aa9d3bb9e3e35-abd8-4f7b-a8e3-90218940fd6b2026-04-28WarningsExact identifier
spl id: 5088c3e5-35c8-005f-e063-6394a90aa9d3
spl set id: bb9e3e35-abd8-4f7b-a8e3-90218940fd6b

Reported adverse events (FAERS/openFDA)#

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