MICONAZOLE- antifungal cream 
Galentic Pharma (India) Priva Te Limited

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.

----------

Antifungal

Active Ingredient

Miconazole Nitrate 2%

Uses - Antifungal

Warnings

Do not use:

Directions



Other information.

Protect from freezing. Avoid excessive heat.

Directions

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Keep Out of Reach of Children

Principal Display Panel

Principal Display Panel

Miconazole Nitrate Cream USP 2%


Gal Miconazole.jpg

Miconazole

MICONAZOLE 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-050-0172 in 1 CASE
11 in 1 BOX
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/18/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

Revised: 7/2013
Document Id: 3484819a-ee23-4388-bafa-c3ee839ddae8
Set id: 853f5d10-99c3-4fdc-87b9-0ee6826e84ad
Version: 4
Effective Time: 20130723
 
Galentic Pharma (India) Priva Te Limited