NDC Code(s) : 64011-246-01
Packager : Lumara Health, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

gynazole 1Butoconazole Nitrate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64011-246
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTOCONAZOLE NITRATE(UNII: 4805237NP5)
(BUTOCONAZOLE - UNII:0Q771797PH) 		BUTOCONAZOLE NITRATE100 mg in 5 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64011-246-011 in 1 CARTON
15.8 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200923 12/27/2012

PRINCIPAL DISPLAY PANEL

Rx Only

GYNAZOLE • 1®

Butoconazole Nitrate Vaginal Cream USP, 2%

The applicator delivers approximately 5 g cream, containing 100 mg butoconazole nitrate.

For Vaginal Use Only.

IN ONE PREFILLED DISPOSABLE APPLICATOR

Net Wt 5.8 g

8F2E6ZLC2 Carton Image.jpg