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RxNorm Names

SAFE-GUARD (fenbendazole) paste
[Schering Corporation]


Category DEA Schedule Marketing Status
OTC ANIMAL DRUG LABEL New Animal Drug Application
Drug Label Sections

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.

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
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.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN

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

Restricted drug (California) - use only as directed.

Store at or below 25°C (77°F).

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

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
SAFE-GUARD 
fenbendazole paste
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:57926-083
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fenbendazole (Fenbendazole) Fenbendazole100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Propylene Glycol 
Glycerin 
Sorbitol 
Sodium Hydroxide 
Water 
Methylparaben 
Propylparaben 
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
NADANADA12064805/10/2010
SAFE-GUARD 
fenbendazole paste
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:57926-084
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fenbendazole (Fenbendazole) Fenbendazole100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Propylene Glycol 
Glycerin 
Sorbitol 
Sodium Hydroxide 
Water 
Methylparaben 
Propylparaben 
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
NADANADA12064805/10/2010
SAFE-GUARD 
fenbendazole paste
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:57926-085
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fenbendazole (Fenbendazole) Fenbendazole100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Propylene Glycol 
Glycerin 
Sorbitol 
Sodium Hydroxide 
Water 
Methylparaben 
Propylparaben 
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
NADANADA13287207/22/2011
SAFE-GUARD 
fenbendazole paste
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:57926-093
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fenbendazole (Fenbendazole) Fenbendazole100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Propylene Glycol 
Glycerin 
Sorbitol 
Sodium Hydroxide 
Water 
Methylparaben 
Propylparaben 
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE, CINNAMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57926-093-481 in 1 CARTON
157 g in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12064807/22/2011
Labeler - Schering Corporation (001317601)
Establishment
NameAddressID/FEIBusiness Operations
Intervet Production S.A.771867553MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
DPT Laboratories, Ltd.832224526MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Intervet Mexico S.A. de C.V.588215863API MANUFACTURE

Revised: 3/2013
 
Schering Corporation

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