Your browser does not support JavaScript! NAIL MD (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]
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NAIL MD (miconazole nitrate) cream
[OMG Medical Group, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

do not use on children under two years of age except under the advce and supervision of a doctor

stop use and ask a doctor if irritation occurs, if condition worsesn, 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

aqua (deionized water), biotin, dimethyl sulfone (msm), ethyoxydiglycol, ethylhexylglycerin, hydrolyzed keratin proteins, hydroxyethylcellulose, phenoxyethanol, polysorbate 20, sd alcohol 40B

miconazole nitrate 2% USP

Topical antifungal

uses

antifungal drying agent

is indicated for candida albicans, trichophyton rubrum, malassezia furfur, trichophyton mentagrophytes

as well as somegram postivie bacteria

lessens the signs of nail dystophy (nail damage caused by trauma or diseas such as fungal infection)

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 making sure to coat both the nail and cuticle completely

other information

store at controlled room temperature 15-30 degrees celsius (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

keep this and all medications out of the reach of children

image description

NAIL MD 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55992-711
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE200 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
BIOTIN 
WATER 
DIMETHYL SULFONE 
BIS-ETHOXYDIGLYCOL SUCCINATE 
ETHYLHEXYLGLYCERIN 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
PHENOXYETHANOL 
POLYSORBATE 20 
ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55992-711-01200 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(55992-711)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(55992-711)

Revised: 12/2013
 
OMG Medical Group, LLC

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