DERMASANA- miconazole nitrate cream

DermaSana by

Drug Labeling and Warnings

DermaSana by is a Otc medication manufactured, distributed, or labeled by OMG Medical Group, LLC, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

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

miconazole nitrate 2% USP

triclosan 0.3% USP

purpose

topical antifungal

topical antibacterial

KEEP OUT OF REACH OF CHILDREN

Keep this and all medications our of the reach of children

directions

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

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMASANA 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55992-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	200 mg  in 1 mg
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	30 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55992-023-01	200 mg in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/14/2013

Labeler - OMG Medical Group, LLC (038837214)

Establishment
Name	Address	ID/FEI	Business Operations
OMG Medical Group, LLC		038837214	repack(55992-023)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture(55992-023)