FDA.reportPublic FDA data

Conazol Cream

Manufacturer
MarcasUSA LLC | Laboratorios Liomont, S.A. de C.V.
Effective date
2019-01-15
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 22:58:12

Label at a glance#

ProductConazol
Active ingredientMICONAZOLE NITRATE
Label structure26 sections

Dosage and administration

wash 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 athlete's foot, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for the athlete's foot and ringworm, use daily for 4 weeks ...

Storage and handling

Store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Miconazole nitrate 2% 		Purpose
Antifungal

INDICATIONS & USAGE SECTION

Uses

OTC - PURPOSE SECTION

  • effective in the treatment of most athlete's foot, jock
    itch and ringworm
  • relieves itching, cracking, burning and discomfort
    associated with these conditions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on children less than 2 years of age unless
directed by a doctor

When using this product

OTC - WHEN USING SECTION

• avoid contact with the eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • irritation occurs
  • there is no improvement of athlete's foot or ringworm
    within 4 weeks or jock itch within 2 weeks

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash 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 athlete's foot, pay special attention to the spaces
    between the toes; wear well-fitting, ventilated shoes,
    and change shoes and socks at least once daily
  • for the athlete's foot and ringworm, use daily for 4 weeks
  • for jock itch, use daily for 2 weeks
  • not effective on the scalp or nails

Other Information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

Drug Facts, cont.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

butylated hidroxyanisole, caprylic/capic triglyceride,
carbomer 980, emulsifying wax, glycerin, methylparaben,
propylene glycol, propylparaben, purified water,
triethanolamine

SPL UNCLASSIFIED SECTION

Questions? Call Toll-Free 1-800-428-9489 ¿Preguntas? Llame gratis al 1-800-428-9489
Manufactured by / Hecho Por

Laboratorios Liomont, S.A. de C.V. A, Lopez Mateos 68, Cuajimalpa, 05000 Mexico, D.F. Mexico.
Distributed by / Distribuido por: MarcasUSA, LLC, El Segundo CA 90245

SPL UNCLASSIFIED SECTION

Datos de Medicamento

OTC - ACTIVE INGREDIENT SECTION

Ingrediente Activo
Nitrato de miconazol 2% 		Propósito
Antimicótico

Usos

OTC - PURPOSE SECTION

  • eficaz en el tratamiento de la mayoría del pie de atleta y la tiña inguinal
  • alivia la comezón, grietas, ardor y molestias asociadas con estas condiciones

Precauciones

WARNINGS SECTION

Sólo para uso externo

No lo use

OTC - DO NOT USE SECTION

en niños menores de 2 años de edad a menos
que lo indique un médico

Al utilizar este producto

OTC - WHEN USING SECTION

  • evite el contacto con los ojos

Pare su uso consulte al médico, si

OTC - ASK DOCTOR SECTION

  • presenta irritación
  • no hay mejoria del pie de atleta o tiña en un plazo de 4
    semanas o tiña inguinal dentro de 2 semanas

Mantener fuera del alcance de los niños.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

En caso de ingestión, obtenga ayuda médica o contacte a
un Poison Control Center inmediatamente.

Modo de Empleo

DOSAGE & ADMINISTRATION SECTION

  • limpie y seque bien el área afectada
  • aplique una capa fina del producto sobre el área
    afectada dos veces al diá (mañana y noche) o según
    las indicaciones de un médico
  • supervise a los niños en el uso de este producto
  • para el pie de atleta, poner especial atención a los espacios
    entre los dedos de los pies, llevar zapatos ventilados y ajustados,
    cambiar los calcetines y zapatos al menos una vez al dia
  • para el pie de atleta, usar diariamente por 4 semanas
  • para tiña inguinal, usar diariamente por 2 semanas
  • no es eficaz en el cuero cabelludo o las uñas

Otra información

STORAGE AND HANDLING SECTION

  • almacene a 20° a 25° C (68° a 77° F)

INACTIVE INGREDIENT SECTION

Datos de Medicamento, cont.

Ingredientes Inactivos

INACTIVE INGREDIENT SECTION

hidroxianisol butilado, triglicérido caprilico/cáprico,
carbomero 980, cera emulsionante, glicerina,
metilparabeno, propilenglicol, propilparabeno, agua
purificada, trietanolamina

SPL UNCLASSIFIED SECTION

Questions? Call Toll-Free 1-800-428-9489 ¿Preguntas? Llame gratis al 1-800-428-9489
Manufactured by / Hecho Por

Laboratorios Liomont, S.A. de C.V. A, Lopez Mateos 68, Cuajimalpa, 05000 Mexico, D.F. Mexico.
Distributed by / Distribuido por: MarcasUSA, LLC, El Segundo CA 90245

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.05 oz (30 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Works Fast to Get you Back In Action

NDC 75940-121-30

Conazol Antifungal

Cures Most Athlete's Foot

Cura la Mayoria del Ple de Atleta

Fast Relief, Absorbs Quickly, Odorless

NET WT
1.05 OZ (30g)

Container LabelContainer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121948Conazol Antifungal 2 % Topical CreamPSN10
998483miconazole nitrate 2 % Topical CreamPSN10
2121948miconazole nitrate 20 MG/ML Topical Cream [Conazol Miconazole]SBD10
998483miconazole nitrate 20 MG/ML Topical CreamSCD10
2121948Conazol Antifungal 2 % Topical CreamSY10
2121948Conazol Miconazole 20 MG/ML Topical CreamSY10
998483miconazole nitrate 2 % Topical CreamSY10

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75940-121-022021-01-29C16284748780-1ba0f9c33-2e41-a910-e053-dadaa90a0b85Conazol Cream
75940-121-302021-01-29C16284748780-1ba0f9c33-2e41-a910-e053-dadaa90a0b85Conazol Cream
75940-121-462021-01-29C16284748780-1ba0f9c33-2e41-a910-e053-dadaa90a0b85Conazol Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75940-121-02Conazol2 g in 1 PACKETCREAM210
75940-121-30Conazol30 g in 1 TUBECREAM3010
75940-121-46Conazol130 g in 1 CANCREAM13010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75940-121CONAZOL (MICONAZOLE NITRATE) CREAM [MARCASUSA LLC]10Legacy NDC, 3 package rows20190116_cbd28006-06d9-4e1c-96bb-40034e2b3649.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K9
MICONAZOLEACTIVE MOIETY7NNO0D7S5M9
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U9
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E9
GLYCERININACTIVE INGREDIENTPDC6A3C0OX9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V39
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH9
TRICAPRININACTIVE INGREDIENTO1PB8EU98M9
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK9
WATERINACTIVE INGREDIENT059QF0KO0R9

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
75940-12175940-121-30, 75940-121-46, 75940-121-02

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
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
TRICAPRINO1PB8EU98MIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 358 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2ULOTION / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USUPPOSITORY / VAGINAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TRANSDERMAL150 mgExact identifier — unii candidate
9 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCONCENTRATE / ORAL0.08 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates

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
f67c02e9-302f-4276-ae26-707372e1e54dcbd28006-06d9-4e1c-96bb-40034e2b36492019-01-15WarningsExact identifier
spl id: f67c02e9-302f-4276-ae26-707372e1e54d
spl set id: cbd28006-06d9-4e1c-96bb-40034e2b3649

Reported adverse events (FAERS/openFDA)#

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