Label: SAFE-GUARD- fenbendazole suspension

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

Drug Label Information

Updated February 12, 2013

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

  • SPL UNCLASSIFIED SECTION

    Dewormer

    for Goats

    Suspension 10%
    (100 mg/mL)

    NOT FOR HUMAN USE

  • INDICATIONS

    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) is achieved when 2.3 mL of the drug are given for each 100 lb body weight.

    EXAMPLES:
    Body Weight
    Goats:
    Amount
    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

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

  • RESIDUE WARNINGS

    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.

  • SPL UNCLASSIFIED SECTION

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

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

  • SPL UNCLASSIFIED SECTION

    Made in France

    Distributed by: Intervet Inc.
    Millsboro, DE 19966
    www.intervetusa.com

  • SPL UNCLASSIFIED SECTION

    NADA # 128-620, Approved by FDA

  • PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label

    intervet

    safe-guard®
    (fenbendazole)

    Dewormer
    for Goats

    Suspension 10%
    (100 mg/mL)

    NOT FOR HUMAN USE

    RESIDUE WARNINGS: 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.

    Consult your veterinarian for
    assistance in the diagnosis, treat-
    ment and control of parasitism.

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

    125 mL (4.2 fl oz)

    092310 LPFI240 01

    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 (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:57926-089-01125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12862009/16/2009
    Labeler - Schering Corporation (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Mexico S.A. de C.V.588215863API MANUFACTURE