Label: SAFE-GUARD- fenbendazole suspension

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • SPL UNCLASSIFIED SECTION

    Dewormer

    for Goats

    Suspension 10%
    (100 mg/mL)

    NOT FOR HUMAN USE

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  • 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.

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  • 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 lb 0.6 mL
    50 lb 1.2 mL
    75 lb 1.7 mL
    100 lb 2.3 mL
    125 lb 2.9 mL

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

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  • 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.

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  • 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.

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  • 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.

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  • SPL UNCLASSIFIED SECTION

    Made in France

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

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  • SPL UNCLASSIFIED SECTION

    NADA # 128-620, Approved by FDA

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  • 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
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  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    fenbendazole suspension
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57926-089
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fenbendazole (Fenbendazole) Fenbendazole 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    methylparaben  
    propylparaben  
    silicon dioxide  
    carboxymethylcellulose sodium  
    povidones  
    trisodium citrate dihydrate  
    citric acid monohydrate  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57926-089-01 125 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA128620 09/16/2009
    Labeler - Schering Corporation (001317601)
    Establishment
    Name Address ID/FEI Business Operations
    Intervet Production S.A. 771867553 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Intervet Mexico S.A. de C.V. 588215863 API MANUFACTURE
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