Label: SAFE-GUARD- fenbendazole suspension

  • NDC Code(s): 57926-088-01, 57926-088-02, 57926-088-03
  • Packager: Merck Sharp & Dohme Corp.
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated September 10, 2021

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


    INDICATIONS: Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight 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 & 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).

    Goats - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.


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


    Body WeightAmountBody WeightAmount
    100 lb2.3 mL25 lb0.6 mL
    200 lb4.6 mL50 lb1.2 mL
    300 lb6.9 mL75 lb1.7 mL
    400 lb9.2 mL100 lb2.3 mL
    500 lb11.5 mL125 lb2.9 mL
    1000 lb23.0 mL
    1500 lb34.5 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.


    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


    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.


    Store at or below 25°C (77°F).
    Protect from freezing. Shake well before use.
    Restricted drug (California) – use only as directed.


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

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

    Approved by FDA under NADA # 128-620
    ©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
    Rev. 09/20

    367235 R3

  • PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label



    for Beef & Dairy Cattle
    and Goats

    Suspension 10%
    (100 mg/mL)

    Withdrawal Periods and Residue Warnings: Milk
    taken from cows during treatment and for 48 hours
    after the last treatment must not be used for human
    consumption. Cattle must not be slaughtered for
    human consumption within 8 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.

    Goats must not be slaughtered for human consumption
    within 6 days following last treatment with this drug
    product. 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.


    1 Gallon (3,785 mL)

    Animal Health

    386508 R4

    PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label
    fenbendazole suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-088
    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)  
    povidone, unspecified (UNII: FZ989GH94E)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    water (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-088-013785 mL in 1 BOTTLE
    2NDC:57926-088-021000 mL in 1 BOTTLE
    3NDC:57926-088-0310000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Merck Sharp & Dohme Corp. (001317601)
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553MANUFACTURE