NAIL MD- tolnafate, triclosan spray

Nail MD by

Drug Labeling and Warnings

Nail MD 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 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

INACTIVE INGREDIENT

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

ACTIVE INGREDIENT

miconazole nitrate 2% USP

PURPOSE

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 OUT OF REACH OF CHILDREN

keep this and all medications out of the reach of children

INTENDED USE OF THE DEVICE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAIL MD 
tolnafate, triclosan spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55992-717
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	Triclosan	20 mg  in 1 mg
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	100 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FUSIDIC ACID (UNII: 59XE10C19C)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55992-717-01	100 mg in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/14/2013

Labeler - OMG Medical Group, LLC (038837214)

Establishment
Name	Address	ID/FEI	Business Operations
OMG Medical Group, LLC		038837214	repack(55992-717)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture(55992-717)