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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
- ACTIVE INGREDIENT
- PURPOSE
- uses
- directions
- other information
- KEEP OUT OF REACH OF CHILDREN
- INTENDED USE OF THE DEVICE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAIL MD
tolnafate, triclosan sprayProduct 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)