Label: SAFE-GUARD- fenbendazole suspension

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

Drug Label Information

Updated September 13, 2021

If you are a consumer or patient please visit this version.

  • INDICATIONS:

    Goats - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of:

    Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Administer orally. The recommended dose of 2.3 mg/lb (5 mg/kg) is achieved when 2.3 mL of the drug are given for each 100 lb body weight.

    Dosing Examples for Goats:

    Body WeightAmount
    25 lb0.6 mL
    50 lb1.2 mL
    75 lb1.7 mL
    100 lb2.3 mL
    125 lb2.9 mL

    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.

    Fenbendazole (active ingred.) made in China. Formulated in France.

  • WARNINGS

    WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. 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.

  • WARNINGS

    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.

  • STORAGE AND HANDLING

    Store at or below 25°C (77°F). Protect from freezing. Shake well before use.

    Restricted drug (California) - Use only as directed.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Intervet Inc
    (d/b/a Merck Animal Health)

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

    LOT NO:

    EXP
    DATE:

    Rev. 09/20

    Approved by FDA under
    NADA # 128-620

    387770 R11

  • PRINCIPAL DISPLAY PANEL - 125 mL Bottle Label

    safe-guard®
    (fenbendazole)

    Dewormer
    for Goats

    Suspension 10%
    (100mg/mL)

    Withdrawal Periods and Residue
    Warnings: Goats must not be
    slaughtered for human consumption
    within 6 days following treatment.
    Because a milk discard time has
    not been established, do not use
    in lactating goats.

    Consult your veterinarian for
    assistance in the diagnosis, treatment
    and control of parasitism.

    MERCK
    Animal Health

    125 mL (4.2 fl oz)

    368607 R6

    PRINCIPAL DISPLAY PANEL - 125 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    fenbendazole suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-089
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    povidone, unspecified (UNII: FZ989GH94E)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-089-01125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12862009/20/1983
    Labeler - Schering Corporation (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd420823163API MANUFACTURE