NDC Code(s) : 66663-103-04, 66663-103-00
Packager : Jazz Pharmaceuticals Commercial Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AVC Vaginalsulfanilamide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66663-103
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFANILAMIDE(UNII: 21240MF57M)
(SULFANILAMIDE - UNII:21240MF57M) 		SULFANILAMIDE15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARIC ACID(UNII: 4ELV7Z65AP)
PEG-2 STEARATE(UNII: 94YQ11Y95F)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
TROLAMINE(UNII: 9O3K93S3TK)
WATER(UNII: 059QF0KO0R)
LACTIC ACID(UNII: 33X04XA5AT)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66663-103-041 in 1 CARTON
1113 g in 1 TUBE, WITH APPLICATOR
2NDC:66663-103-001 in 1 CARTON
2113 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA006530 06/05/1965

PRINCIPAL DISPLAY PANEL

NDC 66663-103-04

4 ounces vaginal cream with applicator

AVC ® CREAM
(sulfanilamide) 15%

Bottom Carton Label

Contains: sulfanilamide 15% in a water-miscible, non-staining base made from lactose, propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, trolamine, and water buffered with lactic acid to an acid pH of approximately 4.3.

Usual dose: 1 applicatorful (about 6 g) intra-vaginally once or twice daily. Improvements in symptoms should occur within a few days, but treatment should be continued for a period of 30 days

Back Carton Label

LIFT HERE

Product Information inside carton.

Top Carton Label

Directions for use of applicator are printed under tear-away panel
of carton.

Rx only.

Storage: Store at room temperature (below 86°F). Protect from cold.
Product darkens with age. Potency is maintained throughout
labeled shelf-life when stored as directed.

111747

Manufactured for: Azur Pharma, Inc.

1818 Market Street Suite 2350

Philadelphia, PA 19103, www.azurpharma.com


Manufactured by: DPT Laboratories, Ltd.

San Antonio, TX 78215

AVC® is a registered trademark of Azur Pharma International II Limited.

AVCCt-11-03

Product Carton LabelProduct Carton Label