ProHeart 6: Product Information (Page 3 of 3)

STORAGE INFORMATION

Store the unconstituted product at or below 25°C (77°F). Do not expose to light for extended periods of time. After constitution, the product is stable for 8 weeks stored under refrigeration at 2° to 8°C (36° to 46°F).

HOW SUPPLIED

ProHeart 6 is available in the following three package sizes.

1. 1-Pack 2. 5-Pack 3. 10-Pack
20 mL vial product: 20 mL vial product: 20 mL vial product:
1 — 10% moxidectin sterile microspheres 5 — 10% moxidectin sterile microspheres 10 — 10% moxidectin sterile microspheres
— 598 mg/vial — 598 mg/vial — 598 mg/vial
1 — Sterile vehicle — 17 mL/vial 5 — Sterile vehicle — 17 mL/vial 10 — Sterile vehicle — 17 mL/vial

Client Information Sheet

Client Information Sheet
(click image for full-size original)

Distributed by: Zoetis Inc. Kalamazoo, MI 49007
All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.
© 2020 Zoetis Services LLC. All rights reserved. PRO-00309ZOETIS PETCARE

zoetis

Distributed by Zoetis Inc., Kalamazoo, MI 49007

Approved by FDA under NADA # 141-189

Revised: May 2021

40031007

PRINCIPAL DISPLAY PANEL — 1 Vial Kit Carton

1 Vial Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 Vial Kit Carton

5 Vial Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Vial Kit Carton

10 Vial Kit Carton
(click image for full-size original)
PROHEART 6 moxidectin kit
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-3670
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-3670-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 VIAL, MULTI-DOSE 10 mL
Part 2 1 VIAL, MULTI-DOSE 17 mL
Part 1 of 2
PROHEART moxidectin injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 3.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISTEARIN
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Part 2 of 2
STERILE VEHICLE inert injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 17 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
PROHEART 6 moxidectin kit
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-3671
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-3671-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 5 VIAL, MULTI-DOSE 88 mL
Part 2 5 VIAL, MULTI-DOSE 85 mL
Part 1 of 2
PROHEART moxidectin injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 3.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISTEARIN
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 17.6 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Part 2 of 2
STERILE VEHICLE inert injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 17 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
PROHEART 6 moxidectin kit
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-3672
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-3672-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 VIAL, MULTI-DOSE 176 mL
Part 2 10 VIAL, MULTI-DOSE 170 mL
Part 1 of 2
PROHEART moxidectin injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 3.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISTEARIN
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 17.6 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Part 2 of 2
STERILE VEHICLE inert injection
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 17 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141189 06/06/2001
Labeler — Zoetis Inc. (828851555)

Revised: 06/2021 Zoetis Inc.

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