Monistat 3 Combination Pack Triple Action

Name: Monistat 3 Combination Pack Triple Action

Monistat 3 Triple Action System

Drug Facts

Active ingredients Purpose
Miconazole nitrate (200 mg in each vaginal insert) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal

Inactive ingredients

  • vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide
  • external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

PRINCIPAL DISPLAY PANEL - kit carton

NDC-30014-002-03

MONISTAT®3
COMBINATION PACK
Miconazole Nitrate Vaginal Inserts (200mg) and Miconazole Nitrate Cream (2%)

ORTHO
CLINICALLY PROVEN
Multi-Symptom Relief

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

3 OVULE® Inserts With 3 Applicators
PLUS External Cream

Net Wt 3 OVULE® Inserts
+ 0.32 oz (9g) Tube

MONISTAT 3 COMBINATION PACK  TRIPLE ACTION
miconazole nitrate kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30014-002
Packaging
# Item Code Package Description
1 NDC:30014-002-03 1 KIT (KIT) in 1 PACKAGE, COMBINATION
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 POUCH
Part 2 1 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate suppository
Product Information
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (Miconazole) Miconazole Nitrate 40 mg
Packaging
# Item Code Package Description
1 3 POUCH (POUCH) in 1 KIT
1 1 SUPPOSITORY (SUPPOSITORY) in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 04/15/2010
Part 2 of 2
MICONASOLE NITRATE 
miconazole nitrate cream
Product Information
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g
Packaging
# Item Code Package Description
1 9 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 04/15/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 04/15/2010
Labeler - McNeil, PPC, Inc. (801375143)
Revised: 04/2010   McNeil, PPC, Inc.
(web3)