Label: SAFE-GUARD- fenbendazole suspension

  • Category: OTC ANIMAL DRUG LABEL

Drug Label Information

Updated February 8, 2013

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  • INDICATIONS

    Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight for the removal and control of: Lungworm (Dictyocaulus viviparus); Stomach worm (adults): brown stomach worm (Ostertagia ostertagi); Stomach worms (adults and fourth stage larvae): barberpole worm (Haemonchus contortus and H. placei), and small stomach worm (Trichostrongylus axei); Intestinal worms (adults and fourth stage larvae): hookworm (Bunostomum phlebotomum), thread-necked intestinal worm (Nematodirus helvetianus), small intestinal worm (Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus colubriformis) and nodular worm (Oesophagostomum radiatum).

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

  • DIRECTIONS

    Determine the proper dose according to estimated body weight. 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.

    EXAMPLES

    Cattle:Body WeightAmount
    100 lb2.3 mL
    200 lb4.6 mL
    300 lb6.9 mL
    400 lb9.2 mL
    500 lb11.5 mL  
    1000 lb    23.0 mL  
    1500 lb    34.5 mL  
    Goats:Body WeightAmount
      25 lb0.6 mL
      50 lb1.2 mL
      75 lb1.7 mL
    100 lb2.3 mL
    125 lb2.9 mL

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

  • STORAGE AND HANDLING

    Restricted drug (California).

    Use only as directed.

    Store at or below 25°C (77°F).

    Protect from freezing.

    Shake well before use.

    For Use in Animals Only.

  • RESIDUE WARNING

    RESIDUE WARNINGS: Cattle must not be slaughtered within 8 days following treatment. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Goats must not be slaughtered for food within 6 days following treatment. Because a withdrawal time in milk has not been established, do not use in lactating goats. For dairy cattle, there is no milk withdrawal period.

  • SPL UNCLASSIFIED SECTION

    Made in Fance

    Distributed by: Intervet Inc., Millsboro, DE 19966

    NADA # 128-620, Approved by FDA

  • PRINCIPAL DISPLAY PANEL - 1,000 mL label

    intervet

    safe-guard®
    (fenbendazole)

    Dewormer

    for Beef & Dairy Cattle and Goats

    Suspension 10% (100 mg/mL)

    RESIDUE WARNINGS: Cattle must not be slaughtered
    within 8 days following treatment. A withdrawal period
    has not been established for this product in pre-ruminat-
    ing calves. Do not use in calves to be processed for veal.
    Goats must not be slaughtered for food within 6 days
    following treatment. Because a withdrawal time in milk
    has not been established, do not use in lactating goats.
    For dairy cattle, there is no milk withdrawal period.

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

    Keep this and all medication out of the reach of children.

    1,000 mL (33.8 fl oz)

    093241 LPFI240 01

    Principal Display Panel - 1,000 mL label
    Principal Display Panel - 1,000 mL label
  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    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)  
    carboxymethylcellulose sodium (UNII: K679OBS311)  
    povidones (UNII: FZ989GH94E)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-088-021000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12862009/25/2009
    Labeler - Schering Corporation (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553ANALYSIS, MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Mexico S.A. de C.V.588215863API MANUFACTURE