fungoid tincture

Manufacturer: Pedinol Pharmacal, Inc. | EMS Acquisition Corp.
Effective date: 2024-10-17
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:26:59

Label at a glance#

Productfungoid tincture

Active ingredientMICONAZOLE NITRATE

Label structure10 sections

Indications and uses

cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) for effective relief of itchy, scaly skin between the toes

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 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 if condition...

Contacts and useful links#

PhoneLabel contact1-800-321-4576

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2% USP

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
for effective relief of itchy, scaly skin between the toes

Warnings

WARNINGS SECTION

For external use only

Flammable:

SPL UNCLASSIFIED SECTION

Do not use while smoking or near heat or flame.

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.
if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

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 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 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
if condition persists longer, consult a doctor
this product is not effective on scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

store at controlled room temperature 15-30 ^oC (59-86 ^oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-321-4576

Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC0884-0293-01

PEDiNOL®

fungoid ^®tincture

miconazole nitrate 2%

topical antifungal

1 fl. oz. (29.57 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998526	Fungoid 2 % tincture treatment kit	PSN	8
998525	miconazole nitrate 2 % Topical Solution	PSN	8
998526	miconazole nitrate 20 MG/ML Topical Solution [Fungoid]	SBD	8
998525	miconazole nitrate 20 MG/ML Topical Solution	SCD	8
998526	Fungoid 2 % Topical Tincture	SY	8
998526	Fungoid 20 MG/ML Topical Solution	SY	8
998525	miconazole nitrate 2 % Topical Solution	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MICONAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0884-0293-01	fungoid tincture	29.57 mL in 1 BOTTLE, WITH APPLICATOR	TINCTURE	29.57		8
0884-0293-01	fungoid tincture	1 in 1 CARTON	TINCTURE	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0884-0293	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241019_250d0a66-01d1-4aba-8f24-4cb4ca529fda.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0884-0293-01	ML - Milliliter	0884-0293	c8854e7a-8786-48ac-91e1-b9ab9ded7731	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	1
Acetic Acid	INACTIVE INGREDIENT	Q40Q9N063P	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	1
Laureth-4	INACTIVE INGREDIENT	6HQ855798J	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

fungoid tincture
miconazole nitrate
ACETIC ACID
BENZYL ALCOHOL
ISOPROPYL ALCOHOL
LAURETH-4
WATER
MICONAZOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0884-0293	0884-0293-01

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
ACETIC ACID	Q40Q9N063P	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURETH-4	6HQ855798J	IACT
WATER	059QF0KO0R	IACT
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIB

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 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Laureth-4	LAURETH-4	6HQ855798J	SOLUTION / TOPICAL	5.22 %w/v		Exact identifier — unii+route 8 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	GEL / TOPICAL		60 mg	Exact identifier — unii+route 8 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	LOTION / TOPICAL	1.3 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	SOLUTION / TOPICAL	5.22 %w/v		Exact identifier — unii+route 8 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	GEL / TOPICAL		60 mg	Exact identifier — unii+route 8 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	LOTION / TOPICAL	1.3 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 6 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
fungoid tincture	MICONAZOLE NITRATE	Pedinol Pharmacal, Inc.	250d0a66-01d1-4aba-8f24-4cb4ca529fda	2024-10-17	Warnings	Exact identifier ndc (package): 0884-0293-01 ndc (product): 0884-0293 ndc11 (package): 00884029301 spl id: 24ae5b13-853c-1311-e063-6394a90aa6ac spl set id: 250d0a66-01d1-4aba-8f24-4cb4ca529fda

Reported adverse events (FAERS/openFDA)#

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