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FDA Approval

Liquid Polibar Plus

CompanyE-Z-EM Canada Inc (DUNS: 204211163)

Effective Date

February 1, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Barium sulfate(1.05 g in 1 mL)

Registrants (1)

DUNS Number

002041226

Manufacturing Establishments (1)

E-Z-EM Canada Inc

Labeler

E-Z-EM Canada Inc

Registrant

E-Z-EM, INC.

DUNS Number

204211163

Products (2)

Liquid Polibar Plus

NDC Product Code

32909-167

Route of Administration

ORAL, RECTAL

Effective Date

February 1, 2021

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 1.05 g in 1 mL

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

acaciaInactive

Code: 5C5403N26OClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

hydrochloric acidInactive

Code: QTT17582CBClass: IACT

potassium chlorideInactive

Code: 660YQ98I10Class: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

carrageenanInactive

Code: 5C69YCD2YJClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

Liquid Polibar Plus

NDC Product Code

32909-168

Route of Administration

ORAL, RECTAL

Effective Date

February 1, 2021

Ingredients

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

hydrochloric acidInactive

Code: QTT17582CBClass: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

potassium chlorideInactive

Code: 660YQ98I10Class: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 1.05 g in 1 mL

acaciaInactive

Code: 5C5403N26OClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

carrageenanInactive

Code: 5C69YCD2YJClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

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