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., Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dewormer

for Goats

Suspension 10%
(100 mg/mL)

NOT FOR HUMAN USE

INDICATIONS

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) is achieved when 2.3 mL of the drug are given for each 100 lb body weight.

EXAMPLES: Body Weight	Goats: 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

Store at or below 25°C (77°F). Protect from freezing. Shake well before use. Restricted drug (California) - Use only as directed.

RESIDUE WARNINGS

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.

SPL UNCLASSIFIED SECTION

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

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

SPL UNCLASSIFIED SECTION

Made in France

Distributed by: Intervet Inc.
Millsboro, DE 19966
www.intervetusa.com

SPL UNCLASSIFIED SECTION

NADA # 128-620, Approved by FDA

PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label

intervet

safe-guard®
(fenbendazole)

Dewormer
for Goats

Suspension 10%
(100 mg/mL)

NOT FOR HUMAN USE

RESIDUE WARNINGS: 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.

Consult your veterinarian for
assistance in the diagnosis, treat-
ment and control of parasitism.

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

125 mL (4.2 fl oz)

092310 LPFI240 01

INGREDIENTS AND APPEARANCE

SAFE-GUARD 
fenbendazole suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57926-089
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: 57926-089-01	125 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 - Schering Corporation (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