SAFE-GUARD (FENBENDAZOLE) POWDER [SCHERING CORPORATION]

SAFE-GUARD (FENBENDAZOLE) POWDER [SCHERING CORPORATION]
PDF | XML

NDC 57926-090-25
Set ID e1bb5aa8-3316-47f1-be79-cdbcd62b7222
Category OTC ANIMAL DRUG LABEL
Packager Schering Corporation
Generic Name
Product Class
Product Number
Application Number NADA131675
  • SPL UNCLASSIFIED SECTION

    CATTLE: Dairy and Beef Cattle SWINE: Growing pigs, gilts, pregnant sows, and boars HORSES

    Zoo and Wildlife Animals

    Growing Turkeys

    MUST BE MIXED BEFORE FEEDING ACCORDING TO DIRECTIONS AND PERMITTED CLAIMS. FOR USE IN MANUFACTURED FEEDS ONLY.

  • ACTIVE DRUG INGREDIENT

    Fenbendazole 200 grams per kilogram (90.7 grams per pound).

  • INERT INGREDIENTS

    Roughage Products or Roughage Products and Calcium Carbonate; and Mineral Oil or Soybean Oil.

  • CATTLE

    Dairy and Beef Cattle

    FOR THE REMOVAL AND CONTROL OF:

    Lungworms: (Dictyocaulus viviparus).

    Stomach worms: Barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei).

    Intestinal worms: Hookworms (Bunostomum phlebotomum), threadnecked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora).

    Bankrupt worms: (Trichostrongylus colubriformis).

    Nodular worms: (Oesophagostomum radiatum).

  • DOSAGE REGIMEN

    5 mg fenbendazole per kg body weight in a one (1) day treatment (2.27 mg fenbendazole per pound).

    EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE

    For a one (1) day treatment, mix the following quantities of SAFE-GUARD® 20% Type A Medicated Article into the daily ration according to body weight and number of cattle per pen.

    Amount of SAFE-GUARD® 20% Type A Medicated Article for:
    Body Weight10 Cattle20 Cattle100 Cattle
    lbs.kgglbs.glbs.glbs.
    20090.7230.05460.102300.5
    400181.4460.10920.204601.0
    600272.2690.151380.306901.5
    800362.9920.201840.409202.0
    1000453.61140.252280.5011402.5
    1400635.01600.353200.7016003.5

    Feed as the sole ration for one (1) day. No prior withdrawal of feed or water necessary. When feed containing SAFE-GUARD® has been fed for 1 day and blended according to the above rates based on weight and number of cattle treated, a total intake of 2.27 mg fenbendazole per pound of body weight is assured. Cattle feed containing SAFE-GUARD® can be fed pelleted or as meal.

    FREE-CHOICE FEEDS

    Free-choice feed must be formulated to provide a total of 5 mg per kg body weight over 3 to 6 days. (Only a licensed medicated feed mill may manufacture the dry or liquid free choice feeds following the approved formulas.)

    Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks.

  • GENERAL USE DIRECTIONS

    It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.

  • CAUTION

    Due to the possible variation in animal feeding behavior, underdosing may occur in individual animals. Underdosing may encourage the development of parasite resistance. It is recommended that parasite resistance be monitored following the use of any anthelmintic with the use of a fecal egg count reduction test program.

  • WARNING

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

    RESIDUE WARNING

    Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle, the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

  • SWINE

    Growing pigs, gilts, pregnant sows, and boars

    FOR THE REMOVAL AND CONTROL OF:

    Lungworms: (Metastrongylus apri, Metastrongylus pudendotectus).

    Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); whipworms, adult and larvae (L2, L3, L4 stages - intestinal mucosal forms) (Trichuris suis).

    Kidney worms: Adult and larvae (Stephanurus dentatus).

  • DOSAGE REGIMEN

    9 mg fenbendazole per kg body weight (4.08 mg fenbendazole per pound) to be fed as the sole ration over a period of 3 to 12 days.

    EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE

    Average daily feed consumptionAmount of SAFE-GUARD® 20% Type A Medicated Article added to each ton of swine feed based on weight and average feed consumption
    Treatment Period
    Pig Wt. (lbs.)lbs. of Feed3 Days6 Days12 Days
    lbs.Gramslbs.Gramslbs.Grams
    302.250.401820.20910.1046
    503.200.472130.241070.1254
    754.250.532410.271210.1461
    1005.300.572580.291290.1565
    1506.800.663010.331510.1776
    2008.000.753410.381710.1986

    Feed as the sole ration for three (3) to twelve (12) consecutive days. No prior withdrawal of feed or water necessary. When feed containing SAFE-GUARD® has been blended according to the above rates based on pig weight and average daily feed consumption, and is then fed for 3-12 days, a total intake of 9 mg fenbendazole per kilogram body weight (4.08 mg fenbendazole per pound) is assured. Swine feeds containing SAFE-GUARD® can be fed pelleted or as meal.

  • GENERAL USE DIRECTIONS

    It is recommended that SAFE-GUARD® 20%Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20%Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20%Type A Medicated Article.

  • WARNING

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

    RESIDUE WARNING

    There is no pre-slaughter withdrawal period as SAFE-GUARD® can be fed to day of slaughter.

  • HORSES

    FOR THE CONTROL OF:

    Large strongyles: (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.) Small strongyles: (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.) Pinworms: (Oxyuris equi) Ascarids: (Parascaris equorum)

  • DOSAGE REGIMEN

    For the control of large strongyles, small strongyles, and pinworms the recommended dose is 5 mg fenbendazole per kg body weight (2.27 mg fenbendazole per pound) in a ONE (1) DAY treatment. For the control of ascarids the recommended dose is 10 mg fenbendazole per kg body weight (4.54 mg fenbendazole per pound) in a ONE (1) DAY treatment.

    All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed.

    EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE

    For a ONE (1) DAY treatment, mix the following quantities of SAFE-GUARD® 20% Type A Medicated Article into the daily ration according to body weight and dose.

    Amount of SAFE-GUARD® 20% Type A Medicated Article
    Body WeightFor dose of 2.27 mg fenbendazole/lb body weightFor dose of 4.54 mg fenbendazole/lb body weight
    lbs.gramsgrams
    2002.274.54
    4004.549.08
    6006.8113.62
    8009.0818.16
    100011.3522.70
    120013.6227.24

    Feed for ONE (1) DAY as above. No prior withdrawal of feed or water is necessary. Horse feed containing SAFE-GUARD® 20% can be fed pelleted or as a meal.

    Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection.

  • GENERAL USE DIRECTIONS

    It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.

  • ANIMAL SAFETY

    There are no known contraindications for the use of fenbendazole in horses. Side effects associated with SAFE-GUARD® 20% (fenbendazole) 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).

    SAFE-GUARD® 20% (fenbendazole) 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 reproduction were detected.

  • WARNING

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

    RESIDUE WARNING

    Do not use in horses intended for human consumption.

  • Zoo and Wildlife Animals

    FOR THE REMOVAL AND CONTROL OF

    Internal parasites in hoofed zoo and wildlife animals (see dosage section for specific parasites, animal species and required doses).

  • DOSE/DOSAGE REGIMENS

    Host AnimalRecommended Treatment formg Fenbendazole/kg
    Body Wt./Day
    × Days of Treatment
    Bighorn Sheep (Ovis canadensis canadensis)lungworms: (Protostrongylus spp.)10 mg × 3
    Feral Swine
    (Sus scrofa)
    kidney worms: (Stephanurus dentatus),
    roundworms: (Ascaris suum),
    nodular worms: (Oesophagostomum dentatum)
    3 mg × 3
    Ruminants - subfamily
    antilopinae:

    Persian gazelles
    (Gazella subgutturosa
    subgutturosa)

    Addra gazelle
    (Gazella dama ruficollis)
    Slendorhorn Gazelle
    (Gazella leptoceros)
    Kenya impala
    (Aepyceros melampus rendilis)
    Roosevelt's gazelle
    (Gazella granti roosevelti)
    Indian blackbuck
    (Antilope cervicapra)
    Mhorr gazelle (Gazella dama mhorr)
    Thomson's gazelles
    (Gazella thomsoni thomsoni)

    small stomach worms:
    (Trichostrongylus spp.),
    thread-necked intestinal worms:
    (Nematodirus spp.),
    barberpole worms:
    (Haemonchus spp.),
    whipworms:
    (Trichuris spp.)







    Down Arrow


    2.5 mg × 3







    Down Arrow
    Ruminants - subfamily
    hippotraginae:

    Addax (Addax nasomasculatus)
    Angolan roan antelope
    (Hippotragus equinus cottoni)
    Fringed-ear oryx (Oryx gazella callotis)
    Arabian oryx (Oryx leucoryx)
    Ruminants - subfamily
    caprinae:

    Armenian mouflon (Ovis orientalis gmelini)
    Russian saiga (Saiga tatarica)

    It is recommended that the user exercise judgmental expertise as needed for retreatment within six (6) weeks. This would depend upon the conditions of continued exposure to parasites, condition of treated animals, and ambient temperatures.

  • GENERAL USE DIRECTIONS

    SAFE-GUARD® 20% Type A Medicated Article must be mixed according to directions and at correct concentrations based upon the species to be treated. It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. The correct proportions of premix and feed ingredients should be established for blending into the complete feed. This premix and feed ingredient combination should be thoroughly and uniformly mixed with the complete feed.

    SAFE-GUARD® 20% Type A Medicated Article can be fed to adult and young animals either in a mash or pelleted feed. No prior withdrawal of feed or water is necessary.

  • WARNING

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

  • ANIMAL SAFETY

    No contraindications for the use of fenbendazole in a zoo environment have been established. Administration to breeding and pregnant ruminants at 2 to 22 times the recommended dose has had no apparent adverse effect.

  • RESIDUE WARNING

    Do not use 14 days before or during the hunting season.

  • Growing Turkeys

    FOR THE REMOVAL AND CONTROL OF:

    Gastrointestinal worms: Roundworms, adults and larvae (Ascaridia dissimilis); Cecal worms, adults and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead).

  • DOSAGE REGIMEN

    14.5 g fenbendazole/ton of feed, to be fed as the sole ration for 6 days.

  • GENERAL USE DIRECTIONS

    It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.

  • FEEDING DIRECTIONS

    Medicated feed containing fenbendazole should be fed as the sole ration for six (6) consecutive days to growing turkeys only. No prior withdrawal of feed or water necessary. Growing turkey feeds containing SAFE-GUARD® can be fed pelleted or as meal.

  • WARNING

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

    RESIDUE WARNING

    There is no pre-slaughter withdrawal period as SAFE-GUARD® can be fed to day of slaughter.

  • SPL UNCLASSIFIED SECTION

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

  • STORAGE AND HANDLING

    STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.
    SEE OTHER SIDE FOR CATTLE, SWINE AND HORSES.

  • SPL UNCLASSIFIED SECTION

    Net Weight 25 pounds (11.34 kg)

    Distributed by: Intervet Inc.
    Millsboro, DE 19966

    NADA # 131-675, Approved by FDA

  • PRINCIPAL DISPLAY PANEL - 11.34 kg Bag

    Safe-Guard®
    (fenbendazole)

    Dewormer

    20%Type A Medicated Article

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    fenbendazole powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole200 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-090-251 in 1 BAG
    111.34 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA13167501/31/1984
    Labeler - Schering Corporation (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    ADM Alliance Nutrition, Inc.834721284MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Mexico S.A. de C.V.588215863API MANUFACTURE

Related Drugs