DermaSana

DERMASANA- miconazole nitrate and triclosan cream 
Pure Source

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.

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Warnings

do not use 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 condition worsens, or there is not improvement within four weeks.

for externam use only

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

do not ingest

do not use on open wounds

in case of accidental ingestion, contacgt a physician, emergency medical

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

active ingredient

miconazole nitrate

triclosan

Topical antifungal, topical antibacterial

Uses

antifungal drying agent

antibacterial drying agent

is indicated in the treatment of most fungi, athlete's foot, rignworm, jock itch, candida albicans, trichophyton rubrum, malassezia furfur, trichophyton mentagrophytes, epidemophyton floccsum

is indicated for the treatment of most bacteria, gram postivie bacteria

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

is indicated for most coagulase-negative staphylococci, beta-hemolytic streptococci, corynebaterium species, clostridium species, anaerobic gram-negative bacilli

Keep this and all medications out of the reach of children

inactive ingredients

acetic acid, deionized water, benzyl alcohol, C13-14 isoparaffin, ethylhexylglycerin, laureth-y, parfum, phenoxyethanol, polyacrylamide, polysorbate-20, SD-alcohol 40B

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

other information

store at controlled room temperature 15-30C (59-86F)

protect from heat

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

image description

DERMASANA 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-915
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 mg
TRICLOSAN (TRICLOSAN) TRICLOSAN3 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 Description
1NDC:65121-915-0120 mg in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201303/25/2013
Labeler - Pure Source (969241041)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(65121-915)

Revised: 03/2013
 
Pure Source