Nail MD

NAIL MD- miconazole nitrate liquid 
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 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

Purpose

Topical Antifungal

Keep this and all medications out of the reach of children

Inactive ingredients

Aqua, biotin, dimethyl sulfone, ethoxydiglycol, ethyhexylglycerine, hydrolyzed keratin proteins, hydroxyethylcellulose, phenoxyethanol, polysorbate 20, alcohol 40B

Uses

antifungal drying agent

is indicated for candida albicans, trichophyton rubrum, malassezia furfur, trichophyton mentagrophytes as well as som gram positive bacteria

lessens the signs of nail dystrophy (nail damage caused by trauma or disease 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

image description

NAIL MD 
miconazole nitrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
BIOTIN 
DIMETHYL SULFONE 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ETHYLHEXYLGLYCERIN 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
PHENOXYETHANOL 
POLYSORBATE 20 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:65121-202-0120 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(65121-202)

Revised: 03/2013
 
Pure Source