Antifungal Cream

Manufacturer
Encube Ethicals, Inc. | Encube Ethicals Private Limited
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:35

Label at a glance#

ProductAntifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure13 sections

Dosage and administration

■ clean 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-filling, ventilated shoes, and change shoes and socks at least once daily ■ for athlete's foot and ringworm, use daily for 4...

Storage and handling

■ do not use if foil seal on tube opening is broken or missing ■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use ■ store at room temperature 15°C to 30°C (59°F to 86°F) ■ before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate, USP 2%

PURPOSE

OTC - PURPOSE SECTION

Antifungal

USE(S)

INDICATIONS & USAGE SECTION

■ proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm

■ for effective relief of itching, scaling, cracking, burning, and discomfort

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

on children under 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 DOCTOR IF

OTC - STOP USE SECTION

■ irritation occurs

■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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 (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

■ clean 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-filling, ventilated shoes, and change shoes and socks at least once daily

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

■ if condition lasts longer, contact a doctor

■ this product is not effective on the scalp or nails

OTHER INFORMATION

STORAGE AND HANDLING SECTION

■ do not use if foil seal on tube opening is broken or missing

■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use

■ store at room temperature 15°C to 30°C (59°F to 86°F)

■ before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzoic acid, butylatyIated; hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7stearate, purified water

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antifungal Cream
Miconazole Nitrate Cream, USP 2%

NET WT. 1.5 OZ (42.5 g)


cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN2
998483miconazole nitrate 20 MG/ML Topical CreamSCD2
998483miconazole nitrate 2 % Topical CreamSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-095-06Antifungal Cream1 in 1 CARTONCREAM12
21922-095-06Antifungal Cream42.5 g in 1 TUBECREAM42.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-095-06GM - Gram21922-095f3534f4e-74fd-4d85-8423-03228d3520c712025-11-13

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
21922-09521922-095-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
ndc (package): 21922-095-06
ndc (product): 21922-095
ndc11 (package): 21922009506
spl id: 7d6e5fac-1b6c-49df-8a84-7702c4821c31
spl set id: 8be4bbfa-424c-4ccf-b8bc-65b16c126053

Reported adverse events (FAERS/openFDA)#

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