Label: QUEST- moxidectin gel

  • NDC Code(s): 0856-7441-03
  • Packager: FDAH, Division of Wyeth
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

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  • SPL UNCLASSIFIED SECTION

    2% Equine Oral Gel

    Contains 20 mg moxidectin/mL
    (2.0% w/v)

    DEWORMER & BOTICIDE

    FOR ORAL USE IN HORSES AND PONIES
    SIX MONTHS OF AGE AND OLDER

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  • INDICATIONS

    QUEST (moxidectin) 2% Equine Oral Gel when administered at the recommended dose level of 0.4 mg moxidectin/kg (2.2 lb) body weight is effective in the treatment and control of the following stages of gastrointestinal parasites in horses and ponies:

    Large Strongyles

     
    Strongylus vulgaris – (adults and L 4/L 5 arterial stages)
     
    Strongylus edentatus – (adults and tissue stages)
     
    Triodontophorus brevicauda – (adults)
     
    Triodontophorus serratus – (adults)

    Small Strongyles (adults)

     
    Cyathostomum spp., including
     
    Cyathostomum catinatum
     
    Cyathostomum pateratum
     
    Cylicostephanus spp., including
     
    Cylicostephanus calicatus
     
    Cylicostephanus goldi
     
    Cylicostephanus longibursatus
     
    Cylicostephanus minutus
     
    Cylicocyclus spp., including
     
    Cylicocyclus insigne
     
    Cylicocyclus leptostomum
     
    Cylicocyclus nassatus
     
    Cylicocyclus radiatus
     
    Coronocyclus spp., including
     
    Coronocyclus coronatus
     
    Coronocyclus labiatus
     
    Coronocyclus labratus
     
    Gyalocephalus capitatus
     
    Petrovinema poculatus

    Small Strongyles

     
    Undifferentiated lumenal larvae

    Encysted cyathostomes

     
    Late L 3 and L 4 mucosal cyathostome larvae

    Ascarids

     
    Parascaris equorum – (adults and L 4 larval stages)

    Pinworms

     
    Oxyuris equi – (adults and L 4 larval stages)

    Hairworms

     
    Trichostrongylus axei – (adults)

    Large-mouth stomach worms

     
    Habronema muscae – (adults)

    Horse stomach bots

     
    Gasterophilus intestinalis – (2 nd and 3 rd instars)
     
    Gasterophilus nasalis – (3 rd instars)

    One administration of the recommended dose rate of QUEST (moxidectin) 2% Equine Oral Gel also suppresses strongyle egg production through 84 days. QUEST is indicated for use in horses and ponies, including breeding mares and stallions, and foals six months of age and older.

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  • STRATEGIC PROTECTION PROGRAMS

    Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. For best control of parasites, all horses and ponies should be included in a strategic treatment program, with particular attention given to high performance animals, brood mares, stallions and foals. In foals, initial treatment is recommended at 6 months of age, after which they should be included in a recurrent treatment program. Because QUEST provides effective control of the mucosal stages of small strongyles (encysted cyathostomes), it is useful in reducing the frequency of treatment required for successful strategic equine parasite control. A veterinarian can assist in preparing the best program for your needs.

    QUEST 2% Equine Oral Gel when used at the recommended dose rate suppresses strongyle egg production through 84 days following a single oral administration. This residual strongyle control reduces pasture contamination and provides a period of protection from reinfection for horses and ponies maintained on the same pasture.

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  • MODE OF ACTION

    QUEST 2% Equine Oral Gel acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite. Moxidectin is safe for use in horses and ponies because it does not have the same injurious effect on the mammalian nervous system.

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  • ADMINISTRATION AND DOSAGE

    QUEST (moxidectin) 2% Equine Oral Gel is specially formulated as a palatable gel which is easily administered to horses and ponies. QUEST Gel is packaged in ready-to-use SURE-DIAL® syringes (see diagram of the SURE-DIAL® syringe below). The syringe is calibrated in 50-pound increments, up to 1150 pounds. This enables the administration of the recommended dose level of 0.4 mg moxidectin/kg body weight by choosing a setting consistent with the animal's weight.

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  • HOW TO SET THE DOSE

    Since the dose is based on the weight of the animal, you need to use a scale or weight tape to find each animal's weight before treating with QUEST Gel. Once the weight is known, set the dose for each horse or pony as follows.

    1. Hold the syringe with the capped end pointing to the left and so that you can see the weight measurements and tick marks (small black lines) as shown in the diagram below. Each tick mark relates to 50 lbs. of body weight.
    2. Turn the green dial ring until the left side of the ring lines up with the weight of the animal. In the diagram below, the dial ring is set to dose a 500 lb. animal.
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  • HOW TO GIVE QUEST GEL TO A HORSE OR PONY

    1. Make sure there is no feed in the animal's mouth.
    2. Remove the cap from the end of the syringe. Save the cap for reuse.
    3. Place the tip of the syringe inside the animal's mouth at the space between the teeth.
    4. Gently push the plunger until it stops, depositing the gel on the back of the tongue.
    5. Remove the syringe from the animal's mouth and raise the animal's head slightly to make sure it swallows the gel.
    6. Replace the syringe cap.
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  • TREATING A SECOND HORSE OR PONY WITH THE SAME SYRINGE

    If the first animal you treat weighs less than 1150 lbs., there will be gel left in the syringe. You can use this gel to treat other horses or ponies. To set the next dose, add the weight of the animal you want to treat to the dose setting already on the syringe. For example, if the syringe was first used to treat a 250 lb. animal, the green dial ring is set on 250 lbs. To treat a 500 lb. animal next, move the green dial ring to the 750 lb. marking (250+500=750). You need more than one syringe to treat horses weighing more than 1150 lbs.

    Each syringe of QUEST 2% Equine Oral Gel may be used to treat more than one animal especially when dosing ponies and growing and lighter breeds of horses. The table below will help estimate the number of horses or ponies the contents of each syringe will treat.

    Ponies Light Horses Heavy Horses
    Treated Animals Treated Animals Treated Animals
    Weight (per syringe) Weight (per syringe) Weight (per syringe)
    Age (lbs) (kg) (lbs) (kg) (lbs) (kg)
    *
    A full syringe plus a portion of a second syringe is required to treat horses weighing more than 1150 lb.
    6 months 200 (91) 5 400 (181) 2 550 (250) 2
    9 months 250 (113) 4 500 (227) 2 700 (318) 1
    Mature 450 (204) 2 900 (409) 1 1300 (590) *
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  • ANIMAL SAFETY

    QUEST (moxidectin) 2% Equine Oral Gel can be safely administered at the recommended dose of 0.4 mg moxidectin/kg body weight to horses and ponies of all breeds at least 6 months of age or older. Transient depression, ataxia and recumbency may be seen when very young or debilitated animals are treated. In these instances, supportive care may be advisable.

    Reproductive safety studies demonstrate a wide margin of safety when the product is used in the treatment of estrual and pregnant mares and breeding stallions.

    To report adverse drug reactions or to obtain a copy of the Material Safety Data Sheet (MSDS) call 855-424-7349.

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  • ENVIRONMENTAL SAFETY

    Care should be taken to avoid the release of significant volumes of moxidectin into either ground or free-running water since moxidectin may be injurious to aquatic life. SURE-DIAL® syringes and their contents should be disposed of in an approved landfill or by incineration.

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  • PRECAUTIONS

    QUEST 2% Equine Oral Gel has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

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  • WARNINGS

    Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Do not use in horses intended for human consumption.

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  • HUMAN WARNINGS

    Not for use in humans. Keep this and all drugs out of the reach of children. Do not ingest. If swallowed, induce vomiting. Wash hands and contaminated skin with soap and water. If accidental contact with eyes occurs, flush repeatedly with water. If irritation or any other symptom attributable to exposure to this product persists, consult your physician.

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  • HOW SUPPLIED

    QUEST 2% Equine Oral Gel is available in one syringe applicator size.

    Each SURE-DIAL® syringe contains 0.4 oz (11.3 g) of QUEST 2% Equine Oral Gel which is sufficient to treat a single horse weighing up to 1150 lb, or two or more lighter animals with a combined body weight of up to 1150 lb.

    NDC 0856-7441-03 — 0.4 oz (11.3 g) syringe - 20 mg moxidectin per mL

    Store at or below 77°F (25°C). Avoid freezing. If frozen, thaw completely before use.

    Store partially-used syringes with the cap tightly secured.

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  • SPL UNCLASSIFIED SECTION

    Figure

    Distributed by:
    Fort Dodge Animal Health
    a division of Wyeth
    a wholly owned subsidiary of Pfizer Inc
    New York, New York 10017

    Made in Spain

    Revised March 2012

    P1099-652US/01-12

    NADA 141-087, Approved by FDA

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  • PRINCIPAL DISPLAY PANEL - 11.3 g Syringe Label

    Quest®GEL
    (moxidectin)

    2% Equine Oral Gel
    Contains 20 mg moxidectin/mL (2.0% w/v)
    0.4 oz (11.3 g) moxidectin gel

    HORSE DEWORMER & BOTICIDE
    FOR ORAL USE IN HORSES AND PONIES SIX MONTHS OF AGE AND OLDER

    NDC 0856-7441-03
    ADMINISTRATION AND DOSAGE: Each syringe treats a single horse weighing up to 1150 lb, or two or more lighter
    animals with a combined body weight of up to 1150 lb. Please read entire insert for ADMINISTRATION AND DOSAGE
    and other important information.
    WARNINGS: Extreme caution should be used when administering the product to foals, young and miniature
    horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight
    animals. Do not use in horses intended for human consumption.
    HUMAN WARNINGS: Not for use in humans. Keep this and all drugs out of the reach of children.
    Do not ingest.
    If swallowed, induce vomiting. Wash hands and contaminated skin with soap and water. If accidental contact with
    eyes occurs, flush repeatedly with water. If irritation or any other symptom attributable to exposure to this product
    persists, consult your physician.
    PRECAUTION: QUEST (moxidectin) Oral Gel has been formulated specifically for use in horses and ponies only. This product
    should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.
    STORAGE:
    Store at or below 77°F (25°C). Avoid freezing. If frozen, thaw completely before use. Store partially-used syringe with the cap tightly secured.
    NADA 141-087, Approved by FDA

    Pfizer
    Dist. by: Fort Dodge Animal Health
    a division of Wyeth, a wholly owned
    subsidiary of Pfizer Inc, NY, NY 10017
    Made in Spain

    Lot :

    Exp. Date :

    EA2116-652US/01-12

    PRINCIPAL DISPLAY PANEL - 11.3 g Syringe Label
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  • PRINCIPAL DISPLAY PANEL - 11.3 g Syringe Carton

    QUEST®GEL
    (moxidectin)

    Controls worms and bots PLUS small strongyle larvae and eggs

    For use in horses and
    ponies six months of
    age and older.

    SURE-DIAL® syringe makes administration easy

    HORSE DEWORMER
    & BOTICIDE

    Net Contents: One syringe
    containing 0.4 oz (11.3 g)
    moxidectin gel

    NDC 0856-7441-03

    Reduces eggs to
    minimize bioburden
    on pasture

    Pfizer

    Long-acting protection for horses

    PRINCIPAL DISPLAY PANEL - 11.3 g Syringe Carton
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  • INGREDIENTS AND APPEARANCE
    QUEST 
    moxidectin gel
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:0856-7441
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    moxidectin (moxidectin) moxidectin 20 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0856-7441-03 1 in 1 CARTON
    1 11.8 mL in 1 SYRINGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141087 07/11/1997
    Labeler - FDAH, Division of Wyeth (149957656)
    Registrant - FDAH, Division of Wyeth (131645827)
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Olot S.L.U. 460052343 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Boehringer Ingelheim Vetmedica, Inc. 832511005 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Lederle S.p.A. Catania, Italy 542812040 API MANUFACTURE
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