Anti-Fungal Cream

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Effective date
2020-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:11

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%

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 product avoid 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 20ºC to 25º C (68ºF to 77º F)
  • Lot No. & Exp. Date: see crimp of tube.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
998483miconazole nitrate 2 % Topical CreamSY1

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
47046-152-022022-01-28C16284748780-1d6a99b39-4c13-a426-e053-dadaa90af4c2Anti-Fungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-152-01Anti-Fungal14 g in 1 TUBECREAM141
47046-152-02Anti-Fungal1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-152ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [ANICARE PHARMACEUTICALS PVT. LTD]1Legacy NDC, 2 package rows20201215_b6599a9c-04d5-e214-e053-2995a90ac95d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-15247046-152-01, 47046-152-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
b659a578-bba5-e024-e053-2995a90a61acb6599a9c-04d5-e214-e053-2995a90ac95d2020-12-13WarningsExact identifier
spl id: b659a578-bba5-e024-e053-2995a90a61ac
spl set id: b6599a9c-04d5-e214-e053-2995a90ac95d

Reported adverse events (FAERS/openFDA)#

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