PARASEDGE Multi For Dogs 3 – 9 Lbs: Product Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 3 x 1.0 mL Tubes

PARASEDGE™ Multi for Dogs

(imidacloprid + moxidectin)

Topical Solution

CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

Once-A-Month Topical Solution

  • Prevention of heartworm disease
  • Treatment of Dirofilaria immitis circulating microfilariae
  • Kills adult fleas and is indicated for the treatment of flea infestations
  • Treatment and control of hookworms, roundworms and whipworms
  • Treatment and control of sarcoptic mange
  • For dogs and puppies that are at least 7 weeks of age and 9.1 to 20 lbs.

WARNING

  • DO NOT ADMINISTER THIS PRODUCT ORALLY
  • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
  • Children should not come in contact with application sites for two (2) hours after application

(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information.)

Each tube contains 100 mg of imidaclopid and 25 mg of moxidectin.

Do not use this product on cats.

Keep this and all drugs out of reach of children.

Approved by FDA under ANADA # 200-700

3

1.0 mL Tubes

Label for Dogs 9 to 20 pounds
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3 x 2.5 mL Tubes

PARASEDGE™ Multi for Dogs

(imidacloprid + moxidectin)

Topical Solution

CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

Once-A-Month Topical Solution

  • Prevention of heartworm disease
  • Treatment of Dirofilaria immitis circulating microfilariae
  • Kills adult fleas and is indicated for the treatment of flea infestations
  • Treatment and control of hookworms, roundworms and whipworms
  • Treatment and control of sarcoptic mange
  • For dogs and puppies that are at least 7 weeks of age and 20.1 to 55 lbs.

WARNING

  • DO NOT ADMINISTER THIS PRODUCT ORALLY
  • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
  • Children should not come in contact with application sites for two (2) hours after application

(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information.)

Each tube contains 250 mg of imidaclopid and 62.5 mg of moxidectin.

Do not use this product on cats.

Keep this and all drugs out of reach of children.

Approved by FDA under ANADA # 200-700

3

2.5 mL Tubes

Label for dogs 20 to 55 poundsLabel for dogs 20 to 55 pounds

PRINCIPAL DISPLAY PANEL — 3 x 4.0 mL Tubes

PARASEDGE™ Multi for Dogs

(imidacloprid + moxidectin)

Topical Solution

CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

Once-A-Month Topical Solution

  • Prevention of heartworm disease
  • Treatment of Dirofilaria immitis circulating microfilariae
  • Kills adult flea s and is indicated for the treatment of flea infestations
  • Treatment and control of hookworms, roundworms and whipworms
  • Treatment and control of sarcoptic mange
  • For dogs and puppies that are at least 7 weeks of age and 55.1 to 88 lbs.

WARNING

  • DO NOT ADMINISTER THIS PRODUCT ORALLY
  • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
  • Children should not come in contact with application sites for two (2) hours after application
(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information.)

Each tube contains 400 mg of imidaclopid and 100 mg of moxidectin.

Do not use this product on cats.

Keep this and all drugs out of reach of children.

Approved by FDA under ANADA # 200-700

3

4.0 mL Tubes

Label for dogs 55.1 to 88 pounds
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3 x 5.0 mL Tubes

PARASEDGE™ Multi for Dogs

(imidacloprid + moxidectin)

Topical Solution

CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

Once-A-Month Topical Solution

  • Prevention of heartworm disease
  • Treatment of Dirofilaria immitis circulating microfilariae
  • Kills adult fleas and is indicated for the treatment of flea infestations
  • Treatment and control of hookworms, roundworms and whipworms
  • Treatment and control of sarcoptic mange
  • For dogs and puppies that are at least 7 weeks of age and 88.1 to 110 lbs.

WARNING

  • DO NOT ADMINISTER THIS PRODUCT ORALLY
  • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals.
  • Children should not come in contact with application sites for two (2) hours after application

(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information.)

Each tube contains 500 mg of imidaclopid and 125 mg of moxidectin.

Do not use this product on cats.

Keep this and all drugs out of reach of children.

Approved by FDA under ANADA # 200-700

3

5.0 mL Tubes

Label for dogs 88 to 110 pounds
(click image for full-size original)
PARASEDGE MULTI FOR DOGS 3 — 9 LBS imidacloprid/moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-132
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 100 mg in 1 mL
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Product Characteristics
Color yellow (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-132-09 3 PACKET in 1 CARTON contains a PACKET
1 1 TUBE in 1 PACKET This package is contained within the CARTON (51311-132-09) and contains a TUBE
1 0.40 mL in 1 TUBE This package is contained within a PACKET and a CARTON (51311-132-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200700 02/04/2022
PARASEDGE MULTI FOR DOGS 9.1 — 20 LBS imidacloprid/moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-133
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 100 mg in 1 mL
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Product Characteristics
Color yellow (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-133-20 3 PACKET in 1 CARTON contains a PACKET
1 1 TUBE in 1 PACKET This package is contained within the CARTON (51311-133-20) and contains a TUBE
1 1 mL in 1 TUBE This package is contained within a PACKET and a CARTON (51311-133-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200700 02/04/2022
PARASEDGE MULTI FOR DOGS 20.1 — 55 LBS imidacloprid/moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-134
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 100 mg in 1 mL
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Product Characteristics
Color yellow (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-134-55 3 PACKET in 1 CARTON contains a PACKET
1 1 TUBE in 1 PACKET This package is contained within the CARTON (51311-134-55) and contains a TUBE
1 2.5 mL in 1 TUBE This package is contained within a PACKET and a CARTON (51311-134-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200700 02/04/2022
PARASEDGE MULTI FOR DOGS 55.1 — 88 LBS imidacloprid/moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-135
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 100 mg in 1 mL
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Product Characteristics
Color yellow (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-135-88 3 PACKET in 1 CARTON contains a PACKET
1 1 TUBE in 1 PACKET This package is contained within the CARTON (51311-135-88) and contains a TUBE
1 4.0 mL in 1 TUBE This package is contained within a PACKET and a CARTON (51311-135-88)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200700 02/04/2022
PARASEDGE MULTI FOR DOGS 88.1 — 110 LBS imidacloprid/moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-136
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIDACLOPRID (IMIDACLOPRID) IMIDACLOPRID 100 mg in 1 mL
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Product Characteristics
Color yellow (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-136-11 3 PACKET in 1 CARTON contains a PACKET
1 1 TUBE in 1 PACKET This package is contained within the CARTON (51311-136-11) and contains a TUBE
1 5 mL in 1 TUBE This package is contained within a PACKET and a CARTON (51311-136-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200700 02/04/2022
Labeler — Virbac AH, Inc (131568396)
Registrant — Virbac AH, Inc (131568396)
Establishment
Name Address ID/FEI Operations
Jiangsu Willing Bio-tech Co. Ltd 421366435 api manufacture
Establishment
Name Address ID/FEI Operations
Realoch Pharma Limited 985648796 analysis, manufacture, pack

Revised: 12/2023 Virbac AH, Inc

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