Novana Antifungal Barrier with Miconazole

Manufacturer: Novana Medical, LLC | O.L. PRODUCTS, INC.
Effective date: 2012-04-04
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:31:32

Label at a glance#

ProductNovana Antifungal Barrier with Miconazole

Active ingredientMiconazole Nitrate

Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose
Miconazole Nitrate 2%..............Antifungal

OTC - PURPOSE SECTION

Indications •For effective treatment of athlete's foot (dermatophytosis), jock itch (tinea cruris), and ringworm (tinea corporis). • For the relief of burning, redness, irritation, discomfort, itching, scaling, and cracking.

WARNINGS SECTION

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor. • Avoid contact with the eyes • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions • 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 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.

DOSAGE & ADMINISTRATION SECTION

Use Daily for 2 weeks.
If condition persists, consult a doctor. This product is not effective on scalp or nails.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Cetyl Alcohol,Cod Liver Oil, Diazolidinyl Urea, Dimethicone, Glyceryl Stearate, Lanolin Oil, Methylparaben, Petrolatum, Propanediol, Propylene Glycol, Propylparaben, Sodium Laureth Sulfate, Water, Zinc Oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998483	miconazole nitrate 2 % Topical Cream	PSN	3
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	3
998483	miconazole nitrate 2 % Topical Cream	SY	3

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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76077-400-04	2019-11-13	C162847	48780-1	97449f38-b840-f6ea-e053-dbdaa90aa703	Drug Facts
76077-400-07	2019-11-13	C162847	48780-1	97449f38-b840-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76077-400-04	Novana Antifungal Barrier with Miconazole	120 mL in 1 TUBE	CREAM	120		3
76077-400-07	Novana Antifungal Barrier with Miconazole	210 mL in 1 TUBE	CREAM	210		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76077-400	NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE (MICONAZOLE NITRATE) CREAM [NOVANA MEDICAL, LLC]	3	Legacy NDC, 2 package rows	20120426_164afeb1-d8b1-4b2c-8e07-c1a27550c5ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76077-400-04	GM - Gram	76077-400	41cead7a-ad80-4d26-b119-700debc61a50	1	2013-02-13
76077-400-07	GM - Gram	76077-400	de3e9fd7-91ab-43e2-bc4a-c42943ba205b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	3
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	3
Cod Liver Oil	INACTIVE INGREDIENT	BBL281NWFG	3
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	3
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	3
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	3
Propanediol	INACTIVE INGREDIENT	5965N8W85T	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	3
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3
Zinc Oxide	INACTIVE INGREDIENT	SOI2LOH54Z	3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Novana Antifungal Barrier with Miconazole
Miconazole Nitrate
Miconazole
Water
Cetyl Alcohol
GLYCERYL MONOSTEARATE
Petrolatum
Lanolin
Cod Liver Oil
Propanediol
Sodium Laureth Sulfate
Propylene Glycol
Diazolidinyl Urea
Methylparaben
Propylparaben
Zinc Oxide
Dimethicone

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76077-400	76077-400-04, 76077-400-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Miconazole Nitrate	VW4H1CYW1K	ACTIB
Water	059QF0KO0R	IACT
Cetyl Alcohol	936JST6JCN	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
Petrolatum	4T6H12BN9U	IACT
Lanolin	7EV65EAW6H	IACT
Cod Liver Oil	BBL281NWFG	IACT
Propanediol	5965N8W85T	IACT
Sodium Laureth Sulfate	BPV390UAP0	IACT
Propylene Glycol	6DC9Q167V3	IACT
Diazolidinyl Urea	H5RIZ3MPW4	IACT
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT
Zinc Oxide	SOI2LOH54Z	IACT
Dimethicone	92RU3N3Y1O	IACT

Source Document#

Source XML

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 6 · 310 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Laureth Sulfate	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 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
34463f8e-014f-4ad5-80b3-ad5542a541bd			164afeb1-d8b1-4b2c-8e07-c1a27550c5ad	2012-04-04	Warnings	Exact identifier spl id: 34463f8e-014f-4ad5-80b3-ad5542a541bd spl set id: 164afeb1-d8b1-4b2c-8e07-c1a27550c5ad

Reported adverse events (FAERS/openFDA)#

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