Label: VALBAZEN- albendazole suspension

  • NDC Code(s): 54771-8783-1, 54771-8783-2, 54771-8783-3
  • Packager: Zoetis Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated May 28, 2014

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  • DESCRIPTION

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats for removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms in cattle and sheep and for the treatment of adult liver flukes in nonlactating goats

  • SPL UNCLASSIFIED SECTION

    Active Ingredient:
    Albendazole
    (Equivalent to 113.6 mg/mL)
    11.36%
  • VETERINARY INDICATIONS

    Indications:

    Cattle and sheep: Valbazen is a broad-spectrum anthelmintic effective in the removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms as indicated below.

    Goats: For the treatment of adult liver flukes in nonlactating goats.

    ParasiteCattleSheepGoats
    Adult Liver FlukesFasciola hepaticaFasciola hepatica, Fascioloides magnaFasciola hepatica
    Heads and Segments of TapewormsMoniezia benedeni, M. expansaCommon Tapeworm (Moniezia expansa), Fringed Tapeworm (Thysanosoma actinioides)
    Adult and 4th Stage Larvae of Stomach WormsBrown Stomach Worm, including 4th stage inhibited larvae (Ostertagia ostertagi), Barber Pole Worm (Haemonchus contortus, H. placei), Small Stomach Worm (Trichostrongylus axei)Brown Stomach Worm (Ostertagia circumcincta, Marshallagia marshalli), Barber Pole Worm (Haemonchus contortus), Small Stomach Worm (Trichostrongylus axei)
    Adult and 4th Stage Larvae of Intestinal WormsThread-necked Intestinal Worm (Nematodirus spathiger, N. helvetianus), Small Intestinal Worm (Cooperia punctata, C. oncophora)Thread-necked Intestinal Worm (Nematodirus spathiger, N. filicollis), Cooper's Worm (Cooperia oncophora), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum columbianum), Large-mouth Bowel Worm (Chabertia ovina)
    Adult Stages of Intestinal WormsHookworm (Bunostomum phlebotomum), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum radiatum)
    Adult and 4th Stage Larvae of LungwormsDictyocaulus viviparus
    Adult and Larval Stages of LungwormsDictyocaulus filaria
  • DOSAGE & ADMINISTRATION

    Dosage and Administration: Valbazen Suspension should be administered to cattle and goats at the recommended rate of 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg) and to sheep at the recommended rate of 0.75 mL/25 lb of body weight (equivalent to 3.4 mg of albendazole/lb, 7.5 mg/kg). The following table indicates recommended dosing schedules.

    CattleSheepGoats
    Body WeightDosageBody WeightDosageBody WeightDosage
    250 lb10 mL25 lb0.75 mL25 lb1 mL
    500 lb20 mL50 lb1.5 mL50 lb2 mL
    750 lb30 mL75 lb2.25 mL75 lb3 mL
    1000 lb40 mL100 lb3.0 mL100 lb4 mL
    1250 lb50 mL200 lb6.0 mL125 lb5 mL
    1500 lb60 mL300 lb9.0 mL150 lb6 mL

    Cattle: 1 liter of Valbazen 11.36% Suspension will treat 50 animals weighing 500 lb.

    Sheep: 1 liter of Valbazen 11.36% Suspension will treat 664 animals weighing 50 lb.

    Goats: 1 liter of Valbazen 11.36% Suspension will treat 500 animals weighing 50 lb.

    Valbazen 11.36% Suspension should be given orally using any type of standard dosing gun or dose syringe.

  • SPL UNCLASSIFIED SECTION

    Important: Accurate estimates of the weight of the cattle, sheep, and goats to be treated are essential for most effective results with this product. Animals constantly exposed to internal parasites should be retreated as necessary.

  • RESIDUE WARNING

    Residue Warnings: Cattle must not be slaughtered within 27 days following last treatment. Sheep and Goats must not be slaughtered within 7 days following last treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in lactating does.

  • PRECAUTIONS

    Precaution: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Do not administer to ewes or does during the first 30 days of pregnancy or for 30 days after removal of rams or bucks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

  • SPL UNCLASSIFIED SECTION

    Keep This and All Medication Out of Reach of Children

    Shake Well Before Using

    For Use in Animals Only

  • STORAGE AND HANDLING

    Store at Controlled Room Temperature 20° – 25°C (68° – 77°F)

    Protect From Freezing

    Not for human use

    Restricted Drug (California) - Use only as directed

    Time Label

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    8784000
    13945200

    LOT
    EXP

  • PRINCIPAL DISPLAY PANEL - 1 L/33.8 fl oz Bottle Label

    VALBAZEN®
    (albendazole)

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats
    for removal and control of liver flukes, tapeworms,
    stomach worms (including 4th stage inhibited
    larvae of Ostertagia ostertagi), intestinal worms,
    and lungworms in cattle and sheep and for the
    treatment of adult liver flukes in nonlactating goats

    Active Ingredient
    Albendazole
    (equivalent to 113.6 mg/mL)
    11.36%

    1 L/33.8 fl oz (1 qt 1.8 fl oz)

    NADA #110-048, Approved by FDA

    8784000
    13945100

    zoetis

    PRINCIPAL DISPLAY PANEL - 1 L/33.8 fl oz Bottle Label
  • PRINCIPAL DISPLAY PANEL - 5 L/169 fl oz Bottle Label

    VALBAZEN®
    (albendazole)

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats
    for removal and control of liver flukes, tapeworms,
    stomach worms (including 4th stage inhibited
    larvae of Ostertagia ostertagi), intestinal worms,
    and lungworms in cattle and sheep and for the
    treatment of adult liver flukes in nonlactating goats

    Active Ingredient
    Albendazole
    (equivalent to 113.6 mg/mL)
    11.36%

    5 L/169 fl oz (1 gal 1 qt 9 fl oz)

    NADA #110-048, Approved by FDA

    8785000
    13945600

    zoetis

    PRINCIPAL DISPLAY PANEL - 5 L/169 fl oz Bottle Label
  • PRINCIPAL DISPLAY PANEL - 500 mL/16.9 fl oz Bottle Label

    VALBAZEN®
    (albendazole)

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats
    for removal and control of liver flukes, tapeworms,
    stomach worms (including 4th stage inhibited larvae of
    Ostertagia ostertagi), intestinal worms, and lungworms
    in cattle and sheep and for the treatment of adult liver
    flukes in nonlactating goats

    Active Ingredient:
    Albendazole
    (Equivalent to 113.6 mg/mL)
    11.36%

    500 mL/16.9 fl oz (1 pt 1 fl oz)

    NADA #110-048, Approved by FDA

    zoetis

    PRINCIPAL DISPLAY PANEL - 500 mL/16.9 fl oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    VALBAZEN 
    albendazole suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-8783
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    albendazole (UNII: F4216019LN) (albendazole - UNII:F4216019LN) albendazole113.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 6 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-8783-1500 mL in 1 BOTTLE
    2NDC:54771-8783-21000 mL in 1 BOTTLE
    3NDC:54771-8783-35000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA11004806/13/1989
    Labeler - Zoetis Inc. (828851555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zoetis LLC039055157MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    UQUIFA Mexico, S.A. DE C.V.810105874API MANUFACTURE