Dynarex Antifungal Powder

Manufacturer
Dynarex Corporation
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:14

Label at a glance#

ProductDynarex Antifungal Powder
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Dosage and administration

Sprinkle onto the affected area twice daily. It can be safely applied to broken skin and may also be sprinkled onto clothes and footwear, which come into contact with the infected area.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                     Purpose

Miconazol 2%                          Antifungal

Purpose

OTC - PURPOSE SECTION

Uses

For external treatment of fungal infections such as athlete’s foot, jock itch, sweat rash, infected diaper rash and fungal infections affecting the skin folds e.g. armpits, groin, or under the breasts.

Warnings

WARNINGS SECTION

For external use only.

Consult a doctor or pharmacist before using this product if you:

■ Are sensitive to the listed ingredients or any similar medications ■ Are pregnant, planning a pregnancy or breastfeeding

When using this product:

You may occasionally experience some side effects. These are rare and consist of local skin irritation or rashes, which occur if you are unusually sensitive to the ingredients listed.

Do Not Use

OTC - DO NOT USE SECTION

Do not use:

■ if you are sensitive to any of the active or inactive ingredients listed ■ if the infection is on your scalp or nails.

Cautions

INDICATIONS & USAGE SECTION

Please read this label carefully before use.

• Dynarex Antifungal Powder is not suitable for the treatment of fungal infections of the scalp or nails, and you should talk to your doctor or pharmacist for alternative treatments for these conditions. In order to ensure successful treatment, it is important to use the powder regularly and to continue for at least 10 days after the disappearance of symptoms. This prevents the infection from reoccurring.

• Remember that most fungal infections are very infectious and can easily be passed on to other family members. In order to prevent this happening, it is important to ensure that anyone who has an infection avoids sharing clothes, towels, or shoes with other family members. After applying the powder, wash and dry your hands thoroughly. If your skin condition does not improve after one week’s use, please consult your doctor or pharmacist.

• If you forget to apply the powder, do not apply the missed dose, but apply the next dose as usual and continue as normal. Do not apply two doses at the same time.

Interactions

If you are taking oral anticoagulants (drugs used to thin the blood, such as Warfarin), talk to your doctor or pharmacist before use.

Overdose

Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. In case of accidental ingestion of powder go to the hospital immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Sprinkle onto the affected area twice daily. It can be safely applied to broken skin and may also be sprinkled onto clothes and footwear, which come into contact with the infected area.

Other information

SPL UNCLASSIFIED SECTION

Keep the medicine in the original packaging in a dry place, at a temperature not exceeding 30ºC/86ºF. Protect from light. Do not use after the expiry date shown on the pack.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

Do not let the powder get into your eyes. This product contains talc. Do not breathe in the powder as this may cause irritation of the airways. This is especially important for children and infants. If swallowed, contact a poison control center immediately.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, talc.

Principal Display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dynarex Antifungal Powder 1236

AntiPowGP.jpg

Antifungal PowderAntifungal Powder

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN4
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD4
998461miconazole nitrate 2 % Topical PowderSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-316-01Dynarex Antifungal Powder85 g in 1 BOTTLE, PLASTICPOWDER854
67777-316-02Dynarex Antifungal Powder24 in 1 CASEPOWDER244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-316DYNAREX ANTIFUNGAL POWDER (MICONAZOLE) POWDER [DYNAREX CORPORATION]4Legacy NDC, 2 package rows20241122_1e335cf8-eb08-40b4-abad-7a71bd2283d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-316-01GM - Gram67777-316db071d52-757d-4998-92af-29bc292f9f3c12023-08-08
67777-316-02GM - Gram67777-316a8c09071-27c4-490e-8bcc-707949709a4512023-08-08

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-31667777-316-01, 67777-316-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
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
27591cc7-3de3-0679-e063-6294a90a5b441e335cf8-eb08-40b4-abad-7a71bd2283d72024-11-20WarningsExact identifier
spl id: 27591cc7-3de3-0679-e063-6294a90a5b44
spl set id: 1e335cf8-eb08-40b4-abad-7a71bd2283d7

Reported adverse events (FAERS/openFDA)#

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