NDC Code(s) : 55301-730-41
Packager : Exchange Select

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Miconazole 7Miconazole Nitrate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55301-730
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE(UNII: VW4H1CYW1K)
(MICONAZOLE - UNII:7NNO0D7S5M) 		MICONAZOLE NITRATE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MINERAL OIL(UNII: T5L8T28FGP)
PEG-5 OLEATE(UNII: 0240V77G50)
PEGOXOL 7 STEARATE(UNII: 3EW5AXE5X5)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (white to off-white, viscous) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55301-730-417 in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074164 07/12/2002

PRINCIPAL DISPLAY PANEL

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Compare to the active ingredient in Monistat® 7 Vaginal Cream*

MICONAZOLE 7
Miconazole Nitrate Vaginal Cream, USP 2%
(Miconazole Nitrate 100 mg per applicator)
VAGINAL ANTIFUNGAL

Cures most vaginal yeast infections
and relieves associated external itching and irritation

7 Day Vaginal Cream (1 Tube)
with 7 Disposable Applicators
Net Wt 1.59 oz (45 g)

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PRINCIPAL DISPLAY PANEL

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