NDC Code(s) : 0591-2131-55
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

azelaic acidazelaic acid GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2131
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZELAIC ACID(UNII: F2VW3D43YT)
(AZELAIC ACID - UNII:F2VW3D43YT) 		AZELAIC ACID0.15 g in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERYL MONOOLEATE(UNII: C4YAD5F5G6)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-2131-551 in 1 CARTON 19/11/2018
150 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208011 11/19/2018

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0591-2131-55

Azelaic Acid Gel

15 %

For Topical Use Only – Not for Oral, Ophthalmic, or Intravaginal Use

Rx only

Contains 50 grams

1