NDC Code(s) : 83008-037-00
Packager : Quality Care Products, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac SodiumDiclofenac Sodium GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83008-037(NDC:69097-524)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC SODIUM10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MINERAL OIL(UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
AMMONIA(UNII: 5138Q19F1X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:83008-037-001 in 1 CARTON 08/04/2023
1100 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 ANDA209903 08/04/2023

LABELER - Quality Care Products, LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Quality Care Products, LLC 831276758 relabel(83008-037)

PRINCIPAL DISPLAY PANEL

image description