BARRIER FOR DOGS- imidacloprid, moxidectin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIDACLOPRID (UNII: 3BN7M937V8) (IMIDACLOPRID - UNII:3BN7M937V8), MOXIDECTIN (UNII: NGU5H31YO9) (MOXIDECTIN - UNII:NGU5H31YO9)

Available from:

Aurora Pharmaceutical, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Barrier for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Barrier for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis ). Barrier for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. Barrier for Dogs is also indicated for the treatment and control of the following intestinal parasites: Do not administer this product orally. (See WARNINGS.) Do not use this product (containing 2.5 % moxidectin) on cats.

Product summary:

Applications Per Package 6 x 0.4 mL tubes 6 x 1.0 mL tubes 6 x 2.5 mL tubes 6 x 4.0 mL tubes 6 x 5.0 mL tubes 55-1554 02/2022 Approved by FDA under ANADA # 200-718 MANUFACTURED BY: AURORA PHARMACEUTICAL, INC. NORTHFIELD, MN 55057 www.aurorapharmaceutical.com MANUFACTURED IN U.S.A. Barrier is a trademark of Aurora Pharmaceutical, Inc.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

BARRIER FOR DOGS- IMIDACLOPRID, MOXIDECTIN SOLUTION
AURORA PHARMACEUTICAL, INC.
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BARRIER™ FOR DOGS
(IMIDACLOPRID+MOXIDECTIN)
TOPICAL SOLUTION
ONCE-A-MONTH TOPICAL SOLUTION FOR THE PREVENTION OF HEARTWORM DISEASE,
THE
TREATMENT OF CIRCULATING MICROFILARIAE, KILLS ADULT FLEAS, IS
INDICATED FOR THE
TREATMENT OF FLEA INFESTATIONS, THE TREATMENT AND CONTROL OF SARCOPTIC
MANGE, AS WELL AS THE TREATMENT AND CONTROL OF INTESTINAL PARASITE
INFECTIONS
IN DOGS AND PUPPIES THAT ARE AT LEAST 7 WEEKS OF AGE AND THAT WEIGH AT
LEAST
3 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)
CAUTION:
Federal (U.S.A.) Law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION:
_Barrier for Dogs_ (10 % imidacloprid + 2.5 % moxidectin) is a
colorless to yellow ready-
to-use solution packaged in single dose applicator tubes for topical
treatment of dogs.
The formulation and dosage schedule are designed to provide a minimum
of 4.5 mg/lb
(10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin based on
body weight.
Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The
chemical name for
imidacloprid is
1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine.
Moxidectin is
a semisynthetic macrocyclic lactone endectocide derived from the
actinomycete
_Streptomycetes cyaneogriseus noncyanogenus_. The chemical name for
moxidectin is
[6R, 23E, 25S(E)]-5-0-
Demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-
(methoxyimino) milbemycin B.
INDICATIONS:
_Barrier for Dogs_ is indicated for the prevention of heartworm
disease caused by
_Dirofilaria immitis_ and the treatment of _Dirofilaria immitis_
circulating microfilariae in
heartworm-positive dogs