NDC | 57926-088-01, 57926-088-02, 57926-088-03 |
Set ID | 9188886a-54bc-4c68-9f1d-37a20e031076 |
Category | OTC ANIMAL DRUG LABEL |
Packager | Merck Sharp & Dohme Corp. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NADA128620 |
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INDICATIONS
Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight for the removal and control of:
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- Lungworm (Dictyocaulus viviparus);
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- Stomach worm (adults): brown stomach worm (Ostertagia ostertagi);
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- Stomach worms (adults and fourth stage larvae): barberpole worm (Haemonchus contortus and H. placei) and small stomach worm (Trichostrongylus axei);
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- 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:
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- Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.
- STORAGE AND HANDLING
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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
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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 Health153593 R2
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INGREDIENTS AND APPEARANCE
SAFE-GUARD
fenbendazole suspensionProduct 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) povidone, unspecified (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 09/20/1983 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