Xeomin (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 50 Unit Vial Carton

1 vial
Rx Only
NDC 46783-161-01

incobotulinumtoxinA
XEOMIN^®
FOR INJECTION

For Intramuscular Use

Dispense the enclosed Medication
Guide to each patient.
One single-dose vial per carton.
Discard Unused Portion.

50 units/vial

WARNING: Dosing units of botulinum
toxins are not interchangeable between commercial products.

MERZ AESTHETICS^®

PRINCIPAL DISPLAY PANEL — 100 Unit Vial Carton

1 vial
Rx Only
NDC 46783-160-01

incobotulinumtoxinA
XEOMIN^®
FOR INJECTION

For Intramuscular Use

Dispense the enclosed Medication
Guide to each patient.
One single-dose vial per carton.
Discard Unused Portion.

100 units/vial

WARNING: Dosing units of botulinum
toxins are not interchangeable between commercial products.

MERZ AESTHETICS^®

PRINCIPAL DISPLAY PANEL — 50 Unit Vial Carton — NDC 46783-165-01

1 vial
Rx Only
NDC 46783-165-01

incobotulinumtoxinA
XEOMIN^®
FOR INJECTION

For Intramuscular Use

Dispense the enclosed Medication
Guide to each patient.
One single-dose vial per carton.
Discard Unused Portion.

50 units/vial

WARNING: Dosing units of botulinum
toxins are not interchangeable between commercial products.

MERZ AESTHETICS^®

XEOMIN incobotulinumtoxina injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46783-161 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Botulinum Toxin Type A (Botulinum Toxin Type A) Botulinum Toxin Type A 50 [USP’U]

Inactive Ingredients Ingredient Name Strength Albumin Human Sucrose

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46783-161-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (46783-161-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125360 08/01/2011

XEOMIN incobotulinumtoxina injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46783-160 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Botulinum Toxin Type A (Botulinum Toxin Type A) Botulinum Toxin Type A 100 [USP’U]

Inactive Ingredients Ingredient Name Strength Albumin Human Sucrose

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46783-160-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (46783-160-01) 2 NDC:46783-160-10 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 2 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (46783-160-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125360 08/01/2011

XEOMIN incobotulinumtoxina injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46783-165 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Botulinum Toxin Type A (Botulinum Toxin Type A) Botulinum Toxin Type A 50 [USP’U]

Inactive Ingredients Ingredient Name Strength Albumin Human Sucrose

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46783-165-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (46783-165-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125360 08/01/2011

Labeler — Merz North America, Inc. (028147846)

Establishment
Name	Address	ID/FEI	Operations
Merz Pharma GmbH & Co. KGaA		342543051	MANUFACTURE (46783-160), MANUFACTURE (46783-161), MANUFACTURE (46783-165)

Revised: 09/2022 Merz North America, Inc.