FLUTICASONE: Package Insert and Label Information (Page 3 of 3)

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FLUTICASONE fluticasone propionate spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-680(NDC:60432-264)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 50 ug
Inactive Ingredients
Ingredient Name Strength
WATER
POLYSORBATE 80
ANHYDROUS DEXTROSE
BENZALKONIUM CHLORIDE
PHENYLETHYL ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-680-16 1 BOTTLE, SPRAY in 1 BOX contains a BOTTLE, SPRAY
1 120 SPRAY, METERED in 1 BOTTLE, SPRAY This package is contained within the BOX (55700-680-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078492 09/07/2018
Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 relabel (55700-680)

Revised: 03/2020 Lake Erie Medical DBA Quality Care Products LLC

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