Remedy Antifungal

Manufacturer: Medline Industries, LP
Effective date: 2025-10-29
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:41:04

Label at a glance#

ProductRemedy Antifungal

Active ingredientMICONAZOLE NITRATE

Label structure8 sections

Indications and uses

for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Dosage and administration

Clean the affected area and dry thoroughly Apply a thin layer of powder 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 between spaces in 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, u...

Storage and handling

protect from freezing. Avoid excessive heat. do not use if package is damaged keep dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2.0% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

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
on scalp or nails

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation occurs
there is no improvement within 4 weeks when used for the treatment of athlete's foot or ringworm
there is no improvement within 2 weeks when used for the treatment of 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 the affected area and dry thoroughly
Apply a thin layer of powder 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 between spaces in 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

STORAGE AND HANDLING SECTION

protect from freezing. Avoid excessive heat.
do not use if package is damaged
keep dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Fragrance, Glycerin, Hydrolyzed Soy Protein, Phospholipids, Silica, Sodium Benzoate, Tocopheryl Acetate, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998461	miconazole nitrate 2 % Topical Powder	PSN	7
998461	miconazole nitrate 0.02 MG/MG Topical Powder	SCD	7
998461	miconazole nitrate 2 % Topical Powder	SY	7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0080196528564	GTIN-13: 0080196528564 EAN-13: 0080196528564 GTIN-12: 080196528564 UPC-A: 080196528564 GTIN storage (14 digits): 00080196528564	53329-169_MSC092603_package label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-169-79	Remedy Antifungal	85 g in 1 BOTTLE	POWDER	85		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-169-79	GM - Gram	53329-169	d7f0b2ab-0b3f-4d75-9e74-5193056608bb	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
7-DEHYDROCHOLESTEROL	INACTIVE INGREDIENT	BK1IU07GKF	1
APHANIZOMENON FLOS-AQUAE	INACTIVE INGREDIENT	49VG1X560X	1
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE	INACTIVE INGREDIENT	U73D397055	1
CLOVE	INACTIVE INGREDIENT	K48IKT5321	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	1
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	1
ETHYLENE BRASSYLATE	INACTIVE INGREDIENT	9A87HC7ROD	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
METHYL DIHYDROJASMONATE (SYNTHETIC)	INACTIVE INGREDIENT	3GW44CIE3Y	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STARCH, TAPIOCA	INACTIVE INGREDIENT	24SC3U704I	1
VANILLA	INACTIVE INGREDIENT	Q74T35078H	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
YEAST	INACTIVE INGREDIENT	3NY3SM6B8U	1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

Remedy Antifungal
Miconazole Nitrate
APHANIZOMENON FLOS-AQUAE
GREEN TEA LEAF
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE
7-DEHYDROCHOLESTEROL
GLYCYRRHIZINATE DIPOTASSIUM
ETHYLENE BRASSYLATE
CLOVE
GLYCERIN
SOY PROTEIN
ISOPROPYL MYRISTATE
METHYL DIHYDROJASMONATE (SYNTHETIC)
EGG PHOSPHOLIPIDS
HYDRATED SILICA
SODIUM BENZOATE
.ALPHA.-TOCOPHEROL ACETATE
VANILLA
WATER
YEAST
CORN OIL
STARCH, CORN
MICONAZOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-169	53329-169-79

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
APHANIZOMENON FLOS-AQUAE	49VG1X560X	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE	U73D397055	IACT
7-DEHYDROCHOLESTEROL	BK1IU07GKF	IACT
GLYCYRRHIZINATE DIPOTASSIUM	CA2Y0FE3FX	IACT
ETHYLENE BRASSYLATE	9A87HC7ROD	IACT
CLOVE	K48IKT5321	IACT
GLYCERIN	PDC6A3C0OX	IACT
SOY PROTEIN	R44IWB3RN5	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYL DIHYDROJASMONATE (SYNTHETIC)	3GW44CIE3Y	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
VANILLA	Q74T35078H	IACT
WATER	059QF0KO0R	IACT
YEAST	3NY3SM6B8U	IACT
CORN OIL	8470G57WFM	IACT
STARCH, CORN	O8232NY3SJ	IACT
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2024-10-09	full-release	2026-06-01 00:23:51

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 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii+route 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii+route 20 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	EMULSION / INTRAVENOUS	1.2 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii+route 20 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii+route 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, TAPIOCA	STARCH, TAPIOCA	24SC3U704I	CAPSULE / ORAL	100 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	TABLET / ORAL		48 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii+route 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii+route 20 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	INJECTION, EMULSION / INTRAVENOUS		12852 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	EMULSION / INTRAVENOUS	1.2 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, TAPIOCA	STARCH, TAPIOCA	24SC3U704I	TABLET / ORAL	5 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii+route 20 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii+route 20 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	48.75 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	TABLET / ORAL		48 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii+route 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii+route 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 30 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
Remedy Antifungal	MICONAZOLE NITRATE	Medline Industries, LP	021b4a31-d7f6-4921-b4b1-cbe832eecd93	2025-10-29	Warnings	Exact identifier ndc (package): 53329-169-79 ndc (product): 53329-169 ndc11 (package): 53329016979 spl id: 425303b5-9f9c-efc3-e063-6294a90ae594 spl set id: 021b4a31-d7f6-4921-b4b1-cbe832eecd93

Reported adverse events (FAERS/openFDA)#

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