FDA.reportPublic FDA data

Anti-Fungal Cream

Manufacturer
Universal Distribution Center LLC | Savvy Care And Cosmetics Pvt. Ltd.
Effective date
2024-05-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:12:48

Label at a glance#

ProductAnti-Fungal
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Miconazole Nitrate 2.0%

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • cures most athlete's foot, jock itch, and ringworm.
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

WARNINGS SECTION

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

OTC - WHEN USING SECTION

When using this productavoid contact with eyes.

OTC - STOP USE SECTION

Stop using this product and ask a doctor

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
  • do not use for diaper rash

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • wash affected area and dry thoroughly

  • Apply a thin layer 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day

  • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks

  • if conditions persist longer, ask a doctor

  • this product is not effective on the scalp or nails.

SPL UNCLASSIFIED SECTION

Other information

  • Store between 15ºC to 30º C (59ºF to 86º F)
  • Lot No. & Exp. Date: see crimp of tube.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Benzoic Acid, Butylated Hydroxyanisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

image of package labelimage of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN6
998483miconazole nitrate 20 MG/ML Topical CreamSCD6
998483miconazole nitrate 2 % Topical CreamSY6

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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-021-372022-02-21C16284748780-19d75b9d0-9dba-f424-e053-dadaa90a57ceAnti-Fungal Cream
52000-021-372020-01-31C16284748780-19d75b9d0-9dba-f424-e053-dadaa90a57ceAnti-Fungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-021-40Anti-Fungal14 g in 1 TUBECREAM146
52000-021-41Anti-Fungal1 in 1 BOXCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-021ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]6Current NDC, Legacy NDC, 2 package rows20240522_8f316b0d-d308-4ae6-82c4-39bb0d1d474e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K1
MICONAZOLEACTIVE MOIETY7NNO0D7S5M1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G501
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X51
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-02152000-021-40, 52000-021-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
MINERAL OILT5L8T28FGPIACT
PEG-5 OLEATE0240V77G50IACT
PEGOXOL 7 STEARATE3EW5AXE5X5IACT
WATER059QF0KO0RIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-5 OLEATEPEG-5 OLEATE0240V77G50CREAM / TOPICAL98 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-5 OLEATEPEG-5 OLEATE0240V77G50CREAM / TOPICAL98 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-5 OLEATEPEG-5 OLEATE0240V77G50CREAM / TOPICAL98 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
3 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
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
ndc (package): 52000-021-40
ndc (package): 52000-021-41
ndc (product): 52000-021
ndc11 (package): 52000002141
ndc11 (package): 52000002140
spl id: 18f39e0a-6734-31b9-e063-6294a90a7204
spl set id: 8f316b0d-d308-4ae6-82c4-39bb0d1d474e

Reported adverse events (FAERS/openFDA)#

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