1236-CS Antifungal Powder (Talc Free)

Manufacturer
Dynarex Corporation
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:32

Label at a glance#

Product1236-CS Antifungal Powder (Talc Free)
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Dosage and administration

• Clean the affected area and dry thoroughly. Apply a thin layer over the 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 daily • For athlete's foot and ringworm: use daily for 4 weeks • For j...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2% USP

Purpose

OTC - PURPOSE SECTION

Antifungal

Use(s)

INDICATIONS & USAGE SECTION

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), and ringworm (tinea corporis)

• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching or burning feet.

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

• For diaper rash

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Before use if you are taking anticoagulants such as warfarin

When using this product

OTC - WHEN USING SECTION

• Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Irritation occurs

• There is no improvement within 2 weeks when used for the treatment of jock itch

• There is no improvement within 4 weeks when used for athlete's foot or ringworm

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 over the 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 daily

• For athlete's foot and ringworm: use daily for 4 weeks

• For jock itch: use daily for 2 weeks

• If condition persists longer, consult a doctor

• This product is not effective on the scalp or nails

Other Information

OTHER SAFETY INFORMATION

• Store at Controlled Room Temperature • Do not use if "Remove before Use" seal is missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate

Questions?

OTC - QUESTIONS SECTION

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1236-CS_IN_MASTER1236-CS_IN_MASTER1236-CS Antifungal Powder (Talc Free)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN1
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1
998461miconazole nitrate 2 % Topical PowderSY1

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
67777-313-031236-CS Antifungal Powder (Talc Free)85 g in 1 BOTTLEPOWDER851
67777-313-041236-CS Antifungal Powder (Talc Free)24 in 1 CASEPOWDER241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-3131236-CS ANTIFUNGAL POWDER (TALC FREE) (1236-CCANTIFUNGAL POWDER(TALC FREE)) POWDER [DYNAREX CORPORATION]1Current NDC, 2 package rows20250406_312ba573-4008-83e6-e063-6294a90a4a6d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-31367777-313-03, 67777-313-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
1236-CS Antifungal Powder (Talc Free)1236-CCANTIFUNGAL POWDER(TALC FREE)Dynarex Corporation312ba573-4008-83e6-e063-6294a90a4a6d2025-03-25WarningsExact identifier
ndc (package): 67777-313-04
ndc (package): 67777-313-03
ndc (product): 67777-313
ndc11 (package): 67777031303
ndc11 (package): 67777031304
spl id: 312ba573-4009-83e6-e063-6294a90a4a6d
spl set id: 312ba573-4008-83e6-e063-6294a90a4a6d

Reported adverse events (FAERS/openFDA)#

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