SAFE-GUARD- fenbendazole suspension

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., Intervet Mexico S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS

Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight for the removal and control of: Lungworm (Dictyocaulus viviparus); Stomach worm (adults): brown stomach worm (Ostertagia ostertagi); Stomach worms (adults and fourth stage larvae): barberpole worm (Haemonchus contortus and H. placei), and small stomach worm (Trichostrongylus axei); Intestinal worms (adults and fourth stage larvae): hookworm (Bunostomum phlebotomum), thread-necked intestinal worm (Nematodirus helvetianus), small intestinal worm (Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus colubriformis) and nodular worm (Oesophagostomum radiatum).

Goats - 2.3 mg/lb (5 mg/kg) body weight for the removal and control of: Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.

DIRECTIONS

Determine the proper dose according to estimated body weight. Administer orally. The recommended dose of 2.3 mg/lb (5 mg/kg) of body weight is achieved when 2.3 mL of the drug are given for each 100 lb body weight.

EXAMPLES

Cattle:	Body Weight	Amount
	100 lb	2.3 mL
	200 lb	4.6 mL
	300 lb	6.9 mL
	400 lb	9.2 mL
	500 lb	11.5 mL
	1000 lb	23.0 mL
	1500 lb	34.5 mL
Goats:	Body Weight	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.

STORAGE AND HANDLING

Restricted drug (California).

Use only as directed.

Store at or below 25°C (77°F).

Protect from freezing.

Shake well before use.

For Use in Animals Only.

RESIDUE WARNING

RESIDUE WARNINGS: Cattle must not be slaughtered within 8 days following 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. 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. For dairy cattle, there is no milk withdrawal period.

SPL UNCLASSIFIED SECTION

Made in Fance

Distributed by: Intervet Inc., Millsboro, DE 19966

NADA # 128-620, Approved by FDA

PRINCIPAL DISPLAY PANEL - 1,000 mL label

intervet

safe-guard®
(fenbendazole)

Dewormer

for Beef & Dairy Cattle and Goats

Suspension 10% (100 mg/mL)

RESIDUE WARNINGS: Cattle must not be slaughtered
within 8 days following treatment. A withdrawal period
has not been established for this product in pre-ruminat-
ing calves. Do not use in calves to be processed for veal.
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.
For dairy cattle, there is no milk withdrawal period.

Consult your veterinarian for assistance in the diagnosis,
treatment and control of parasitism.

Keep this and all medication out of the reach of children.

1,000 mL (33.8 fl oz)

093241 LPFI240 01

INGREDIENTS AND APPEARANCE

SAFE-GUARD 
fenbendazole suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57926-088
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 mL

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
silicon dioxide (UNII: ETJ7Z6XBU4)
carboxymethylcellulose sodium (UNII: K679OBS311)
povidones (UNII: FZ989GH94E)
trisodium citrate dihydrate (UNII: B22547B95K)
citric acid monohydrate (UNII: 2968PHW8QP)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57926-088-02	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA128620	09/25/2009

Labeler - Schering Corporation (001317601)

Establishment
Name	Address	ID/FEI	Business Operations
Intervet Production S.A.		771867553	ANALYSIS, MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Intervet Mexico S.A. de C.V.		588215863	API MANUFACTURE