NDC Code(s) : 55700-863-00
Packager : Quality Care Products, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%, GEL
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:55700-863(NDC:21922-009)
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
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
MINERAL OIL(UNII: T5L8T28FGP)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
WATER(UNII: 059QF0KO0R)
AMMONIA(UNII: 5138Q19F1X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-863-001 in 1 CARTON 26/05/2020
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 ANDA210986 05/26/2020

LABELER - Quality Care Products, LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Quality Care Products, LLC 831276758 relabel(55700-863)

PRINCIPAL DISPLAY PANEL

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