Coraxis Topical Solution: Product Information (Page 4 of 4)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 9.1-20 lbs dogs

CORAXIS (moxidectin) Topical Solution for Dogs, 9.1-20 lbs dogs label
(click image for full-size original)

6 Pack
9.1 — 20 lbs

CORAXISTM
(moxidectin)

Topical Solution for Dogs

Once-a-month topical solution for the prevention of heartworm disease caused by Dirofilaria immitis , as well as the treatment and control of hookworm, roundworm and whipworm infections in dogs and puppies that are at least 7 weeks of age and weigh 9.1 to 20 lbs.

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

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 25 mg of moxidectin in a 2.5% moxidectin solution.

Keep this and all drugs out of reach of children.

6 PACK
SIX 1.0 mL TUBES

NADA # 141-417Approved by FDA

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3-9 lbs dogs

CORAXIS (moxidectin) Topical Solution for Dogs, 3-9 lbs dogs label
(click image for full-size original)

6 Pack
3 — 9 lbs

CORAXISTM
(moxidectin)

Topical Solution for Dogs

Once-a-month topical solution for the prevention of heartworm disease caused by Dirofilaria immitis , as well as the treatment and control of hookworm, roundworm and whipworm infections in dogs and puppies that are at least 7 weeks of age and weigh 3 to 9 lbs.

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

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 10 mg of moxidectin in a 2.5% moxidectin solution.

Keep this and all drugs out of reach of children.

6 PACK
SIX 0.4 mL TUBES

NADA # 141-417Approved by FDA

CORAXIS TOPICAL SOLUTION moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-2416
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-2416-02 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 3 TUBE in 1 BLISTER PACK This package is contained within the CARTON (0859-2416-02) and contains a TUBE (0859-2416-01)
1 NDC:0859-2416-01 5 mL in 1 TUBE This package is contained within a BLISTER PACK and a CARTON (0859-2416-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141417 01/14/2019 10/31/2020
CORAXIS TOPICAL SOLUTION moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-2417
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-2417-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TUBE in 1 BLISTER PACK This package is contained within the CARTON (0859-2417-02) and contains a TUBE (0859-2417-01)
1 NDC:0859-2417-01 4 mL in 1 TUBE This package is contained within a BLISTER PACK and a CARTON (0859-2417-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141417 01/14/2019 10/31/2020
CORAXIS TOPICAL SOLUTION moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-2418
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-2418-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TUBE in 1 BLISTER PACK This package is contained within the CARTON (0859-2418-02) and contains a TUBE (0859-2418-01)
1 NDC:0859-2418-01 2.5 mL in 1 TUBE This package is contained within a BLISTER PACK and a CARTON (0859-2418-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141417 01/14/2019 10/31/2020
CORAXIS TOPICAL SOLUTION moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-2419
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-2419-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TUBE in 1 BLISTER PACK This package is contained within the CARTON (0859-2419-02) and contains a TUBE (0859-2419-01)
1 NDC:0859-2419-01 1 mL in 1 TUBE This package is contained within a BLISTER PACK and a CARTON (0859-2419-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141417 01/14/2019 10/31/2020
CORAXIS TOPICAL SOLUTION moxidectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-2420
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0859-2420-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TUBE in 1 BLISTER PACK This package is contained within the CARTON (0859-2420-02) and contains a TUBE (0859-2420-01)
1 NDC:0859-2420-01 0.4 mL in 1 TUBE This package is contained within a BLISTER PACK and a CARTON (0859-2420-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141417 01/14/2019 10/31/2020
Labeler — Bayer HealthCare, LLC Animal Health Division (152266193)

Revised: 10/2020 Bayer HealthCare, LLC Animal Health Division

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