Label: SAFE-GUARD- fenbendazole suspension
- NDC Code(s): 57926-088-02
- Packager: Schering Corporation
- Category: OTC ANIMAL DRUG LABEL
Updated February 8, 2013
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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.
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.
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
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
PRINCIPAL DISPLAY PANEL - 1,000 mL label
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
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