SAFE-GUARD- fenbendazole paste

Safe-guard by

Drug Labeling and Warnings

Safe-guard by is a Animal medication manufactured, distributed, or labeled by Schering Corporation, Intervet Production S.A., DPT Laboratories, Ltd., Intervet Mexico S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

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 - 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 - 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 - 57 g Syringe Label

intervet

safe-guard®
(fenbendazole)

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

FOR USE IN ANIMALS ONLY.
Net Wt. 57 g (2.01 oz)

INGREDIENTS AND APPEARANCE

SAFE-GUARD 
fenbendazole paste

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57926-083
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36)	Fenbendazole	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
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	Item Code (Source)	NDC: 57926-084
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36)	Fenbendazole	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
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	Item Code (Source)	NDC: 57926-085
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36)	Fenbendazole	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
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	Item Code (Source)	NDC: 57926-093
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36)	Fenbendazole	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
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	12/31/2016

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