Label: SAFE-GUARD- fenbendazole paste

  • NDC Code(s): 57926-083-44, 57926-084-46, 57926-085-47, 57926-093-48
  • Packager: Schering Corporation
  • 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 03/13

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

  • Dewormer for Beef & Dairy Cattle
  • FOR THE REMOVAL AND CONTROL OF

    Lungworms: (Dictyocaulus viviparus). Stomach worms: Barberpole worms (Haemonchus contortus), Brown stomach worms (Ostertagia ostertagi), Small stomach worms (Trichostrongylus axei). Intestinal worms: Hookworms (Bunostomum phlebotomum), Thread-necked intestinal worms (Nematodirus helvetianus), Small intestinal worms (Cooperia punctata & C. oncophora), Bankrupt worms (Trichostrongylus colubriformis), Nodular worms (Oesophagostomum radiatum).

    Treats 58 animals of 220 lbs each.

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  • DIRECTIONS

    This cartridge is intended for use only with the dispensing gun designed for this product. To prepare dispensing gun for administration of paste:

    1. Turn plunger rod so that notches face up and retract rod fully.
    2. Insert cartridge and ring into gun handle until flush with rubber gasket. Turn cartridge and ring clockwise to secure cartridge to gun.
    3. Push plunger rod forward until firm contact is made with cartridge plunger.
    4. Turn plunger rod so that notches face downward.
    5. Remove cap from cartridge.
    6. Depress trigger until paste has been ejected. Discard ejected paste. This is to ensure a full initial dose.
    7. One full depression of trigger delivers one dose for a 220 lb animal.
    8. Insert nozzle through the interdental space and deposit paste on back of the tongue by depressing the trigger for the appropriate number of depressions as determined from the table in the dosage section.
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  • DOSAGE

    Safe-Guard® (fenbendazole) Paste is given orally to beef and dairy cattle. The dose is 5 mg fenbendazole/kg (2.3 mg/lb) of body weight or 5 g Safe-Guard® (fenbendazole) Paste per 220 lb body weight (100 kg). Each full depression of the dispensing gun trigger delivers approximately 5 g Safe-Guard® (fenbendazole) Paste.

    Administer according to the following table:

    Cattle Weight No. of Depressions One Tube Will Treat
    220 lb 1 58 head
    440 lb 2 29 head
    660 lb 3 19 head
    880 lb 4 14 head
    1,100 lb 5 11 head
    1,540 lb 7   8 head

    DO NOT UNDERDOSE

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

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  • RESIDUE WARNING

    RESIDUE WARNING
    Cattle must not be slaughtered within 8 days following last 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. In dairy cattle, the milk discard time is zero hours.
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  • WARNINGS

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN

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  • SPL UNCLASSIFIED SECTION

    CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT AND CONTROL OF PARASITISM.

    Restricted drug (California) - use only as directed.

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  • HOW SUPPLIED

    Store at or below 25°C (77°F).

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  • SPL UNCLASSIFIED SECTION

    Manufactured by DPT Laboratories, San Antonio, TX 78215

    Safe-Guard is the property of Intervet International B.V. or affiliated companies or licensors and is protected by copyrights, trademark and other intellectual property laws.

    Copyright © 2011 Intervet International B.V. All rights reserved.

    NADA # 132-872, Approved by FDA
    129671

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  • PRINCIPAL DISPLAY PANEL - 25 g Carton

    intervet

    safe-guard®
    (fenbendazole)

    Equine
    Dewormer

    25 gram Paste 10%
    (100 mg/g)

    PRINCIPAL DISPLAY PANEL - 25 g Carton
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  • PRINCIPAL DISPLAY PANEL - 92 g Carton

    intervet

    safe-guard®
    (fenbendazole)

    Equine
    Dewormer

    92 g Paste 10% (100 mg/g)

    For Use in Animals Only

    One tube deworms 4 (1,000 lb) horses.
    Net Weight 92 g (3.2 oz)

    PRINCIPAL DISPLAY PANEL - 92 g Carton
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  • PRINCIPAL DISPLAY PANEL - 290 g Tube Label

    intervet

    safe-guard®
    (fenbendazole)

    Dewormer

    for Beef & Dairy Cattle
    290 g Paste 10% (100 mg/g)

    For Use in Animals Only

    Net Wt. 290 g (10.2 oz)

    To be used only with Safe-Guard® dosing equipment.

    Principal Display Panel - 290 g Tube Label
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  • PRINCIPAL DISPLAY PANEL - 57 g Tube Label

    intervet

    safe-guard®
    (fenbendazole)

    Equine Dewormer 57 gram Paste 10% (100 mg/g)

    Principal Display Panel - 57 g Tube Label
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  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57926-083
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fenbendazole (Fenbendazole) Fenbendazole 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Propylene Glycol  
    Glycerin  
    Sorbitol  
    Sodium Hydroxide  
    Water  
    Methylparaben  
    Propylparaben  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor APPLE, CINNAMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57926-083-44 1 in 1 CARTON
    1 25 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA120648 05/10/2010
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57926-084
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fenbendazole (Fenbendazole) Fenbendazole 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Propylene Glycol  
    Glycerin  
    Sorbitol  
    Sodium Hydroxide  
    Water  
    Methylparaben  
    Propylparaben  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor APPLE, CINNAMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57926-084-46 1 in 1 CARTON
    1 92 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA120648 05/10/2010
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57926-085
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fenbendazole (Fenbendazole) Fenbendazole 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Propylene Glycol  
    Glycerin  
    Sorbitol  
    Sodium Hydroxide  
    Water  
    Methylparaben  
    Propylparaben  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor APPLE, CINNAMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57926-085-47 1 in 1 CARTON
    1 290 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA132872 07/22/2011
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57926-093
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fenbendazole (Fenbendazole) Fenbendazole 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Propylene Glycol  
    Glycerin  
    Sorbitol  
    Sodium Hydroxide  
    Water  
    Methylparaben  
    Propylparaben  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor APPLE, CINNAMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57926-093-48 1 in 1 CARTON
    1 57 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA120648 07/22/2011
    Labeler - Schering Corporation (001317601)
    Establishment
    Name Address ID/FEI Business Operations
    Intervet Production S.A. 771867553 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    DPT Laboratories, Ltd. 832224526 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Intervet Mexico S.A. de C.V. 588215863 API MANUFACTURE
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