Safe-Guard Fenbendazole

Dosage Form: FOR ANIMAL USE ONLY
intervet

safe-guard®

(fenbendazole)

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.

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.

Made in France

Distributed by: Intervet Inc., Millsboro, DE 19966

NADA # 128-620, Approved by FDA

PRINCIPAL DISPLAY PANEL - 3,785 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-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)

SAFE-GUARD  fenbendazole   suspension

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 57926-088 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fenbendazole (Fenbendazole) Fenbendazole 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength methylparaben   propylparaben   silicon dioxide   carboxymethylcellulose sodium   povidone   trisodium citrate dihydrate   citric acid monohydrate   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 57926-088-01 3785 mL In 1 BOTTLE None

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

Labeler - Schering Corporation (001317601)

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

Revised: 09/2009Schering Corporation