DermaSana

Manufacturer: OMG Medical Group, LLC | Pure Source
Effective date: 2013-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:35:01

Label at a glance#

ProductDermaSana

Active ingredientMICONAZOLE NITRATE, TRICLOSAN

Label structure9 sections

Indications and uses

antifungal drying agent antibacterial drying agent is indicated in the treatment of most fungi athlete's foot (tinea pedis) ringworm (tinea corporis) jock itch (tinea cruris) candida albicans trichophyton rubrum malassezia furfur trichophyton mentagrophytes epidemophyton floccsum is indicated for the treatment of most bacteria gram positive bacteria (such as staphyloocccous aureus) is indicated for certain methici...

Dosage and administration

shake well before using clean and dry affected areas apply twice per day or as recommended by your doctor with the brush applicator a thin layer of the product to the affected areas

Storage and handling

store at controlled room temperature 15-30 degrees celcius (59-86 degrees farenhight) protect from heat keep from freezing, if freezing occurs, thaw out at room temperature and shake well to mix contents back to a solution

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

do not used on children under two years of age except under the advice and supervision of a doctor

stop use and ask a doctor if irritation occurs, if conditions worsens, or there is not improvement within four weeks.

for external use only

avoid contact with eyes, scalp, vagina, penis, scrotum and anus

do not ingest

do not use on open wounds

in case of accidental ingestion contact a physician, emergency medical

do not use if you are known to be sensitive to any of the ingredients in this product

active ingredient

OTC - ACTIVE INGREDIENT SECTION

miconazole nitrate 2% USP

triclosan 0.3% USP

purpose

OTC - PURPOSE SECTION

topical antifungal

topical antibacterial

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications our of the reach of children

directions

DOSAGE & ADMINISTRATION SECTION

shake well before using

clean and dry affected areas

apply twice per day or as recommended by your doctor

with the brush applicator a thin layer of the product to the affected areas

uses

INDICATIONS & USAGE SECTION

antifungal drying agent

antibacterial drying agent

is indicated in the treatment of most fungi

athlete's foot (tinea pedis)

ringworm (tinea corporis)

jock itch (tinea cruris)

candida albicans

trichophyton rubrum

malassezia furfur

trichophyton mentagrophytes

epidemophyton floccsum

is indicated for the treatment of most bacteria

gram positive bacteria (such as staphyloocccous aureus)

is indicated for certain methicillin resistant saphylococcus aureus (MRSA) isolates

is indicated for most coagulase-negative staphylococci

beta hemolytic streptococci

corynebacterium species

clostridium species

anaerobic gram-negative bacilli (such as bacteriodes fragilis)

other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 15-30 degrees celcius (59-86 degrees farenhight)

protect from heat

keep from freezing, if freezing occurs, thaw out at room temperature and shake well to mix contents back to a solution

INACTIVE INGREDIENT SECTION

acetic acid, aqua (deionized water), benzyl alcohol, c13-14 isoparaffin, ethylhexylglycerin, laureth 7, parfum, phenoxyethanol, polyacrylamide, polysorbate 20, sd-alcohol 40B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

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
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55992-023-01	2019-11-27	C162847	48780-1	9855d018-d95e-cd31-e053-dbdaa90ab51a	DermaSana

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55992-023-01	DermaSana	200 mg in 1 PACKAGE	CREAM	200		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55992-023	DERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]	6	Legacy NDC, 1 package rows	20130325_f3e0eb4c-3b09-4d1c-9067-c58b8e06c50f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	6
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	6
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	6
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	6
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	6
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	6
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	6
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	6
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	6
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	6
POLYACRYLAMIDE (10000 MW)	INACTIVE INGREDIENT	E2KR9C9V2I	6
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

DermaSana
Miconazole Nitrate
MICONAZOLE
TRICLOSAN
ACETIC ACID
WATER
BENZYL ALCOHOL
C13-14 ISOPARAFFIN
ETHYLHEXYLGLYCERIN
LAURETH-7
PHENOXYETHANOL
POLYACRYLAMIDE (10000 MW)
POLYSORBATE 20
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55992-023	55992-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIB
TRICLOSAN	4NM5039Y5X	ACTIB
ACETIC ACID	Q40Q9N063P	IACT
WATER	059QF0KO0R	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
LAURETH-7	Z95S6G8201	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYACRYLAMIDE (10000 MW)	E2KR9C9V2I	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
ALCOHOL	3K9958V90M	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 4 · 188 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	TABLET / ORAL	NA		Exact identifier — unii candidate 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRASYNOVIAL		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / RECTAL	129 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTERIAL	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SYRUP / ORAL		10 mg	Exact identifier — unii candidate 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRACAVITARY	0.01 ml		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SUSPENSION / AURICULAR (OTIC)	0.26 %w/v		Exact identifier — unii candidate 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SPRAY, METERED / NASAL	1.2 mg/1ml		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SOLUTION/ DROPS / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SOLUTION / INTRAVENOUS		14 mg	Exact identifier — unii candidate 45 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SOLUTION / ORAL		10 mg	Exact identifier — unii candidate 45 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION, EMULSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		3 mg	Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 45 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 45 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	CREAM / VAGINAL	0.35 %w/w		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 45 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	SOLUTION / SUBCUTANEOUS	0.04 %w/v		Exact identifier — unii candidate 45 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 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
76022b1f-449d-418a-9065-47b565f9efa0			f3e0eb4c-3b09-4d1c-9067-c58b8e06c50f	2013-03-01	Warnings	Exact identifier spl id: 76022b1f-449d-418a-9065-47b565f9efa0 spl set id: f3e0eb4c-3b09-4d1c-9067-c58b8e06c50f

Reported adverse events (FAERS/openFDA)#

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