DERMASANA- miconazole nitrate and triclosan cream 
OMG Medical Group, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DermaSana

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 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

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

image description

DERMASANA 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55992-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE200 mg  in 1 mg
TRICLOSAN (TRICLOSAN) TRICLOSAN30 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
WATER 
BENZYL ALCOHOL 
C13-14 ISOPARAFFIN 
ETHYLHEXYLGLYCERIN 
LAURETH-7 
PHENOXYETHANOL 
POLYACRYLAMIDE (10000 MW) 
POLYSORBATE 20 
ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55992-023-01200 mg in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/14/2013
Labeler - OMG Medical Group, LLC (038837214)
Establishment
NameAddressID/FEIBusiness Operations
OMG Medical Group, LLC038837214repack(55992-023)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(55992-023)

Revised: 3/2013
Document Id: 76022b1f-449d-418a-9065-47b565f9efa0
Set id: f3e0eb4c-3b09-4d1c-9067-c58b8e06c50f
Version: 6
Effective Time: 20130301
 
OMG Medical Group, LLC