SAFE-GUARD (FENBENDAZOLE) PASTE [SCHERING CORPORATION]

SAFE-GUARD (FENBENDAZOLE) PASTE [SCHERING CORPORATION]
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NDC 57926-083-44, 57926-084-46, 57926-085-47, 57926-093-48
Set ID 391b94ab-535c-4a8c-94d1-d3c5de11f81b
Category OTC ANIMAL DRUG LABEL
Packager Merck Sharp & Dohme
Generic Name
Product Class
Product Number
Application Number NADA120648
  • Dewormerfor 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.

  • 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.
  • 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 WeightNo. of DepressionsOne Tube Will Treat
    220 lb158 head
    440 lb229 head
    660 lb319 head
    880 lb414 head
    1,100 lb511 head
    1,540 lb7  8 head

    DO NOT UNDERDOSE

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

  • 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.
  • WARNINGS

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

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

    Restricted drug (California) - use only as directed.

  • HOW SUPPLIED

    Store at or below 25°C (77°F).

  • 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

  • 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
  • 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
  • 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
  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-083
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE, CINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-083-441 in 1 CARTON
    125 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12064806/19/1981
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE, CINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-084-461 in 1 CARTON
    192 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12064806/19/1981
    SAFE-GUARD 
    fenbendazole paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE, CINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-085-471 in 1 CARTON
    1290 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA13287203/07/1984
    Labeler - Merck Sharp & Dohme (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Mexico S.A. de C.V.588215863API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.420823163API MANUFACTURE

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