PANACUR (FENBENDAZOLE) PASTE [SCHERING CORPORATION]

PANACUR (FENBENDAZOLE) PASTE [SCHERING CORPORATION]
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NDC 57926-081-44, 57926-082-48
Set ID f050ba40-bb95-423c-a02b-b0f0c9a46830
Category OTC ANIMAL DRUG LABEL
Packager Schering Corporation
Generic Name
Product Class
Product Number
Application Number NADA120648
  • SPL UNCLASSIFIED SECTION

    Paste 10% (100 mg/g) Equine Dewormer

  • DESCRIPTION

    Panacur® (fenbendazole) Paste 10% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole carbamate.

    The chemical structure is:

    Chemical Structure

    Each gram of Panacur® (fenbendazole) Paste 10% contains 100 mg of fenbendazole and is flavored with artificial apple-cinnamon liquid.

  • ACTIONS

    The antiparasitic action of Panacur® (fenbendazole) Paste 10% is believed to be due to the inhibition of energy metabolism in the parasite.

  • INDICATIONS

    Panacur® (fenbendazole) Paste 10% is indicated for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), encysted early third stage (hypobiotic), late third stage and fourth stage cyathostome larvae, small strongyles, pinworms (Oxyuris equi), ascarids (Parascaris equorum), and arteritis caused by fourth stage larvae of Strongylus vulgaris in horses.

    Panacur® (fenbendazole) Paste 10% is approved for use concomitantly with an approved form of trichlorfon. Trichlorfon is approved for the treatment of stomach bots (Gasterophilus spp.) in horses. Refer to the manufacturer's label for directions for use and cautions for trichlorfon.

  • PRECAUTIONS

    Side effects associated with Panacur® (fenbendazole) Paste 10% could not be established in well-controlled safety studies in horses with single doses as high as 454 mg/lb (1,000 mg/kg) and 15 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly with higher doses, the lethal action of fenbendazole may cause the release of antigens by the dying parasites. This phenomenon may result in either a local or systemic hypersensitive reaction. As with any drug, these reactions should be treated symptomatically.

    Panacur® (fenbendazole) Paste 10% has been evaluated for safety in pregnant mares during all stages of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in stallions with doses as high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproductivity were detected. The recommended dose for control of 4th stage larvae of Strongylus vulgaris, 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days, has not been evaluated for safety in stallions or pregnant mares.

    Internal Parasites

    Regular deworming at intervals of six to eight weeks may be required due to the possibility of reinfection.

    Migrating Tissue Parasites

    In the case of 4th stage larvae of Strongylus vulgaris, treatment and retreatment should be based on the life cycle and the epidemiology. Treatment should be initiated in the spring and repeated in the fall after a six month interval.

    Optimum Deworming Program for control of S. vulgaris

    Optimum reduction of S. vulgaris infections is achieved by reducing the infectivity of the pastures. When horses are running on pasture, in temperate North America, maximum pasture infectivity occurs in October-December. If horses are removed from those pastures in January, pasture infectivity will decline to zero by July 1. Egg production of S. vulgaris is minimal from January through April, peaking in August and declining to minimal values in December.

    Recommended Deworming Program

    **December 1, February 1, April 1, June 1, August 1, October 1.

    The two treatments that are in bold type are the recommended periods when the 5 day treatment regimen for the control of the migrating larvae of S. vulgaris should be performed.

    **For other areas in the world, retreatment periods for the migrating larvae of S. vulgaris may be different; consult with your veterinarian.

  • CAUTIONS

    Keep this and all medication out of the reach of children.

    When using Panacur® (fenbendazole) Paste 10% concomitantly with trichlorfon, refer to the manufacturer's labels for use and cautions for trichlorfon.

  • WARNING

    Do not use in horses intended for human consumption

  • DOSAGE

    Panacur® (fenbendazole) Paste 10% is administered orally at a rate of 2.3 mg/lb (5 mg/kg) for the control of large strongyles, small strongyles, and pinworms. One syringe will deworm a 1,100 lb horse. For foals and weanlings (less than 18 months of age) where ascarids are a common problem, the recommended dose is 4.6 mg/lb (10 mg/kg); one syringe will deworm a 550 lb horse.

    For control of encysted early third stage (hypobiotic), late third stage and fourth stage cyathostome larvae, and fourth stage larvae of Strongylus vulgaris, the recommended dose is 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days; administer one syringe for each 550 Ibs body weight per day.

    SEE PRECAUTIONS FOR RETREATMENT RECOMMENDATIONS.

  • DIRECTIONS FOR USE

    1. Determine the weight of the horse.
    2. Remove syringe tip.
    3. Turn the dial ring until the edge of the ring nearest the tip lines up with zero.
    4. Depress plunger to advance paste to tip.
    5. Now set the dial ring at the graduation nearest the weight of the horse (do not underdose).
    6. Horse's mouth must be free of food.
    7. Insert nozzle of syringe through the interdental space and deposit the paste on the back of the tongue by depressing the plunger.
  • HOW SUPPLIED

    Panacur® (fenbendazole) Paste 10% Equine Dewormer is supplied in 25 g syringes.

    Store at or below 25°C (77°F).

  • SPL UNCLASSIFIED SECTION

    CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT AND CONTROL OF PARASITISM.

  • SPL UNCLASSIFIED SECTION

    Made in France

    Distributed by:
    Intervet Inc.
    Millsboro, DE 19966

    NADA # 120-648, Approved by FDA
    For use in animals only.

  • PRINCIPAL DISPLAY PANEL - 100 mg/g Syringe Carton

    intervet

    panacur®
    (fenbendazole)

    Equine Dewormer

    Equine
    Dewormer
    25 gram Paste 10%
    (100 mg/g)

    PRINCIPAL DISPLAY PANEL - 100 mg/g Syringe Carton
  • PRINCIPAL DISPLAY PANEL - 100 mg/g Syringe Label

    intervet

    panacur®
    (fenbendazole)

    Equine Dewormer 57 gram Paste 10% (100 mg/g)

    FOR USE IN ANIMALS ONLY.
    Net Wt. 57 g (2.01 oz)

    WARNING: DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION.

    DIRECTIONS:

    1. Determine the weight of the horse.
    2. Remove syringe tip.
    3. Turn the dial ring until the edge of the ring nearest the tip lines up with zero.
    4. Depress plunger to advance paste to tip.
    5. Now set the dial ring at the graduation nearest the weight of the horse
      (do not underdose).
    6. Horse's mouth should be free of food.
    7. Insert nozzle of syringe through the interdental space and deposit the paste on
      the back of the tongue by depressing the plunger.

    The contents of one syringe will deworm two 1,250 lb (568 kg) horses at the
    standard dosage rate of 2.3 mg/lb (5 mg/kg). Refer to the carton for dosage and
    full directions for use and for treatment of ascarids, encysted early third stage
    (hypobiotic), late third stage and fourth stage cyathostome larvae and 4th stage
    larvae of Strongylus vulgaris as well as for concomitant use with trichlorfon.
    CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS,
    TREATMENT AND CONTROL OF PARASITISM.
    Each syringe contains 5.7 g of fenbendazole.

    Keep this and all medication out of the reach of children.
    Store at or below 25°C (77°F).

    Manufactured by: DPT Laboratories,
    San Antonio, TX 78215

    Panacur is the property of Intervet International
    B.V. or affiliated companies or licensors and is
    protected by copyrights, trademark and other
    intellectual property laws. Copyright © 2011
    Intervet International B.V. All rights reserved.
    NADA # 120-648, Approved by FDA     129670

    UPC CODE
    021784047159

    PRINCIPAL DISPLAY PANEL - 100 mg/g Syringe Label
  • INGREDIENTS AND APPEARANCE
    PANACUR 
    fenbendazole paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE, CINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-081-441 in 1 CARTON
    125 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12064805/10/2010
    PANACUR 
    fenbendazole paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE, CINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-082-481 in 1 CARTON
    157 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12064807/22/2011
    Labeler - Schering Corporation (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd420823163API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Mexico S.A. de C.V.588215863API MANUFACTURE

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