Leader Medicated

Manufacturer: Cardinal Health Inc.
Effective date: 2012-10-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:44:32

Label at a glance#

ProductLeader Medicated

Active ingredientMICONAZOLE NITRATE

Label structure10 sections

Dosage and administration

clean and dry affected area 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 spaces between 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 ...

Contacts and useful links#

PhoneLabel contact1-866-964-0939

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconozole nitrate2%

Purpose

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

Uses

for the cure of most athlete's foot, jock itch and ringworm

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

do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

clean and dry affected area
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 spaces between 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, consult a doctor
this product is not effective on scalp or nails

Other infomation

OTHER SAFETY INFORMATION

Product settles during shipment. Package contains full net weight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc. Contains no starch

Questions

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Medicated Miconazole Nitrate 2% PowderLeader Medicated Miconazole Nitrate 2% Powder Spray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-653-18	2025-05-01	C162847	48780-1	9d75b9d0-eafa-f424-e053-dadaa90a57ce	Drug Facts
37205-653-18	2020-01-31	C162847	48780-1	9d75b9d0-eafa-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-653-18	GM - Gram	37205-653	3fc7e254-74b6-4cfd-b3ff-ad8fe8660be0	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	1
ALDIOXA	INACTIVE INGREDIENT	8T66I31YNK	1
CHLOROXYLENOL	INACTIVE INGREDIENT	0F32U78V2Q	1
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

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

Leader Medicated
Miconazole nitrate
MICONAZOLE
ALDIOXA
CHLOROXYLENOL
IMIDUREA
POWDERED CELLULOSE
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-653	37205-653-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIM
ALDIOXA	8T66I31YNK	IACT
CHLOROXYLENOL	0F32U78V2Q	IACT
IMIDUREA	M629807ATL	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML · Source PDF

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 · 56 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	CAPSULE / ORAL		2430 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, FILM COATED / ORAL		392 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DISC / EXTRACORPOREAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / BUCCAL	4.5 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	LOTION / TOPICAL		228 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	LIQUID / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CHLOROXYLENOL	CHLOROXYLENOL	0F32U78V2Q	CREAM / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DISC / TOPICAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / SUBLINGUAL	4.5 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, EXTENDED RELEASE / ORAL		156 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CHLOROXYLENOL	CHLOROXYLENOL	0F32U78V2Q	SOLUTION / AURICULAR (OTIC)	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	SHAMPOO / TOPICAL		60 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, DELAYED RELEASE / ORAL	16 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DROPS / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	POWDER, FOR SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii candidate 16 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0e9f81b1-f349-4a5d-b9ce-903da56b1fd5			1a809c94-52df-4593-8665-4efd3a20a581	2025-04-17	Warnings	Exact identifier spl set id: 1a809c94-52df-4593-8665-4efd3a20a581

Reported adverse events (FAERS/openFDA)#

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