SAFE-GUARD- fenbendazole suspension

Safe-Guard by

Drug Labeling and Warnings

Safe-Guard by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp., Intervet Production S.A.. 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.

STORAGE AND HANDLING

Store at or below 25°C (77°F).

Protect from freezing. Shake well before use.

Restricted drug (California) – use only as directed.

For Use in Animals Only.

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 lbs 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
	1,000 lb	23.0 mL
	1,500 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.

SPL UNCLASSIFIED SECTION

Made in France

Distributed by: Intervet Inc., Millsboro, DE 19966
NADA # 128-620, Approved by FDA

PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label

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-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.
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 Gallon (3,785 mL)

MERCK
Animal Health

153593 R2

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, unspecified form (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: 57926-088-01	3785 mL in 1 BOTTLE
2	NDC: 57926-088-02	1000 mL in 1 BOTTLE
3	NDC: 57926-088-03	10000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA128620	09/16/2009

Labeler - Merck Sharp & Dohme Corp. (001317601)

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

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