FDA.reportPublic FDA data

Active Ingredient

Manufacturer
Rida LLC
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:46

Label at a glance#

ProductTerramed Just Think Comfort Jock Itch Antifungal Treatment
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years and over: wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the 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 in case of clogging, clean with a pin  Children under 12 years...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP, 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

● for the relief of symptoms associated with jack itch ( tinea cruris)

● for effective relief of itching, burning, scaling and discomfort and chafing associated with jock itch

Warnings

WARNINGS SECTION

For external use only.

Do not use:
• on scalp
• in or near the mouth or eyes
• for vaginal yeast infections

When using this product, do not get it into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if:
• irritation occurs
• there is no improvement within 2 weeks (for jock itch)

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

Flammable. Keep away from heat, sparks, electrical fire, or flame.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning andnight)
  • supervise children in the 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
  • in case of clogging, clean with a pin 
  • Children under 12 years: ask a doctor 

Other information

SPL UNCLASSIFIED SECTION

  • do not use if seal on the box is broken or is not visible.
  • 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, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998533miconazole nitrate 2 % Topical SprayPSN2
998533miconazole nitrate 20 MG/ML Topical SpraySCD2
998533miconazole nitrate 2 % Topical SpraySY2
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY2

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83004-020-012025-08-20C16284748780-13b156c62-2c21-fb37-e063-e6dba90a4e072acb9027-8f20-4b77-9b45-17fe11622c7c
83004-020-012025-07-29C16284748780-13b156c62-2c21-fb37-e063-e6dba90a4e072acb9027-8f20-4b77-9b45-17fe11622c7c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-020-01Terramed Just Think Comfort Jock Itch Antifungal Treatment120 mL in 1 BOTTLE, SPRAYLIQUID1202
83004-020-01Terramed Just Think Comfort Jock Itch Antifungal Treatment1 in 1 BOXLIQUID12

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
83004-02083004-020-01

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

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
Terramed Just Think Comfort Jock Itch Antifungal TreatmentMICONAZOLE NITRATERida LLC2acb9027-8f20-4b77-9b45-17fe11622c7c2026-05-27WarningsExact identifier
ndc (package): 83004-020-01
ndc (product): 83004-020
ndc11 (package): 83004002001
spl id: 52cf366b-0e84-89ef-e063-6394a90a3967
spl set id: 2acb9027-8f20-4b77-9b45-17fe11622c7c

Reported adverse events (FAERS/openFDA)#

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