NDC Code(s) : 0574-0107-70, 0574-0107-14, 0574-0107-77
Packager : Padagis US LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clotrimazoleclotrimazole LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE(UNII: G07GZ97H65)
(CLOTRIMAZOLE - UNII:G07GZ97H65) 		CLOTRIMAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 16 mm
Flavor Imprint Code PAD;0107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0574-0107-7070 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2005
2NDC:0574-0107-14140 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2005
3NDC:0574-0107-7770 in 1 BOX 12/01/2005
31 in 1 PACKET Type 0: Not a Combination Product12/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076763 12/01/2005

LABELER - Padagis US LLC(967694121)

PRINCIPAL DISPLAY PANEL

NDC 0574-0107-70

Rx Only

Clotrimazole Lozenge (Clotrimazole Troche) 10 mg

DESCRIPTION: Each lozenge contains 10 mg of clotrimazole, [1-(ο-chloro-α,α-diphenylbenzyl)imidazole].

DOSAGE: Each lozenge must be dissolved slowly in the mouth.

See accompanying literature for complete information.

Dispense in tight containers (USP).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Avoid freezing.

70 Lozenges

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