Label: NAIL MD- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55992-711-01 - Packager: OMG Medical Group, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 17, 2013
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAIL MD
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55992-711 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 200 mg in 1 mg Inactive Ingredients Ingredient Name Strength BIOTIN (UNII: 6SO6U10H04) WATER (UNII: 059QF0KO0R) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) BIS-ETHOXYDIGLYCOL SUCCINATE (UNII: YGQ120RH3I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55992-711-01 200 mg in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/14/2013 Labeler - OMG Medical Group, LLC (038837214) Establishment Name Address ID/FEI Business Operations OMG Medical Group, LLC 038837214 repack(55992-711) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(55992-711)
