Label: SAFE-GUARD- fenbendazole powder

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated February 1, 2022

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  • 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.

  • SPL UNCLASSIFIED SECTION

    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.

  • VETERINARY INDICATIONS

    CATTLE: Dairy and Beef Cattle

    FOR THE TREATMENT AND CONTROL OF:

    Lungworms: Adult Dictyocaulus viviparus; Stomach worms: Adult brown stomach worms (Ostertagia ostertagi), Adult and fourth stage larvae barberpole worms (Haemonchus contortus), fourth stage larvae barberpole worms (H. placei), and Adult and fourth stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (Adult and fourth stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).

  • DRUG FEEDING RATE:

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

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

    MIXING DIRECTIONS:

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated cattle feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:

    Cattle Type B Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
    11.041,001 (0.5)
    195.5917,740 (8.9)

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated cattle feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

    The following table gives examples of how some complete Type C medicated feeds can be prepared:

    Cattle Type C Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
    2.20200 (0.1)
    11.021,000 (0.5)

    FEEDING DIRECTIONS:

    Feed as the sole ration for one (1) day. No prior withdrawal of feed or water necessary. Type C medicated cattle feeds containing SAFE-GUARD® 20% can be fed pelleted or as a meal.

    FREE-CHOICE FEEDS: Type C free-choice medicated feed must be manufactured by a licensed feed mill according to an approved formula to provide a total of 5 mg per kg body weight fenbendazole over 3 to 6 days.

  • WARNINGS

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.

    OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

    Withdrawal Periods and Residue Warnings: Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

  • VETERINARY INDICATIONS

    SWINE: Growing pigs, gilts, pregnant sows, and boars

    FOR THE TREATMENT AND CONTROL OF:

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

  • DRUG FEEDING RATE:

    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.

    MIXING DIRECTIONS:

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:

    Swine Type B Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
    11.031,000 (0.5)
    195.5917,740 (8.9)

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

    The following table gives examples of how some complete Type C medicated feeds can be prepared:

    Swine Type C Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
    0.1110 (0.005)
    3.31300 (0.15)

    FEEDING DIRECTIONS:

    Feed as the sole ration for three (3) to twelve (12) consecutive days. No prior withdrawal of feed or water necessary.

    Type C medicated swine feeds containing SAFE-GUARD® 20% can be fed pelleted or as a meal.

  • WARNINGS

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.

    OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.

    Withdrawal Periods: Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product.

  • HORSES

    FOR THE TREATMENT AND 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).

  • DRUG FEEDING RATE:

    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.

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

    MIXING DIRECTIONS:

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated horse feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:

    Equine Type B Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
    110.2510,000 (5.0)
    195.5917,740 (8.9)

    Thoroughly mix SAFE-GUARD® Type A medicated article with equine feed according to the table below to obtain the proper concentration in the Type C medicated feed:

    Equine Type C Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
    50.054,540 (2.27)

    FEEDING DIRECTIONS:

    No prior withdrawal of feed or water necessary. Type C medicated horse feed containing SAFE-GUARD® 20% can also be fed pelleted.

  • WARNINGS

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.

    OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

    Do not use in horses intended for human consumption.

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 131-675

    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.

  • SPL UNCLASSIFIED SECTION

    SEE OTHER SIDE FOR ZOO AND WILDLIFE ANIMALS AND GROWING TURKEYS.

    Net Weight 25 pounds (11.34 kg)

    Lot / Expiration date located below:

    364857 R15

  • Zoo and Wildlife Animals

    FOR THE TREATMENT AND CONTROL OF:

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

  • DRUG FEEDING RATES:

    Host AnimalRecommended Treatment Formg Fenbendazole/kg
    Body Wt./Day
    × Days of Treatment
    Bighorn sheep (Ovis canadensis canadensis) Lungworms: (Protostrongylus spp.) 10 mg/kg/day × 3 days
    Feral swine
    (Sus scrofa)    		Kidney worms: (Stephanurus dentatus),
    Roundworms:(Ascaris suum),
    Nodular worms: (Oesophagostomum dentatum)    		3 mg/kg/day × 3 days
    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/kg/day × 3 days







    Down Arrow
    Ruminants – subfamily
    hippotraginae:
    Addax
    (Addax nasomaculatus)
    Angolan roan antelope
    (Hippotragus equinus cottoni)
    Fringed-ear oryx
    (Oryx gazelle 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.

    MIXING DIRECTIONS:

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated zoo/wildlife animal feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

    The following table gives examples of how some complete Type C medicated feeds can be prepared:

    Feral Swine, Wildlife and Zoo Ruminants & Bighorn Sheep Type C Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated FeedResulting Fenbendazole Concentration in Type C Medicated Feed
    [grams/ton (grams/pound)]
    0.5550 (0.025)
    11.021,000 (0.5)
  • FEEDING DIRECTIONS:

    Type C medicated feeds containing SAFE-GUARD®20% can be fed in either a mash or pelleted form. No prior withdrawal of feed or water is necessary.

  • WARNINGS

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.

  • SPL UNCLASSIFIED SECTION

    OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.

  • RESIDUE WARNING

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

  • Growing Turkeys

    FOR THE TREATMENT 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).

  • DRUG FEEDING RATE:

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

    MIXING DIRECTIONS:

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated turkey feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives an example of how some Type B medicated feed concentrations can be prepared:

    Turkey Type B Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
    5.51500 (0.25)
    195.5917,740 (8.9)

    Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated growing turkey feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

    The following table describes how to obtain the proper concentration in the complete Type C medicated feed:

    Turkey Type C Medicated Feed Instructions
    Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
    0.1614.5 (0.007)

    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. Type C medicated growing turkey feeds containing SAFE-GUARD® 20% can be fed pelleted or as a meal.

  • WARNINGS

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.

    OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.

    Withdrawal Periods: No withdrawal period is required when used according to labeling.

  • SPL UNCLASSIFIED SECTION

    SEE OTHER SIDE FOR CATTLE, SWINE, AND HORSES.

    MERCK
    Animal Health

    Distributed by:
    Intervet Inc. (d/b/a Merck Animal Health)
    Madison, NJ 07940

    ©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
    Madison, NJ 07940

    Rev. 09/2020

  • PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label

    TO OPEN-PULL NARROW TAPE

    safe-guard®
    (fenbendazole)

    Dewormer

    20% Type A
    Medicated Article

    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.

    PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label
  • 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.834721284MEDICATED ANIMAL FEED MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.420823163API MANUFACTURE
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