OZIPCO- fenbendazole paste
Drug Labeling and Warnings
Drug Details [pdf]
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DESCRIPTION:
Ozipco® (fenbendazole) Paste 10% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenyl-thio)-2-benzimidazole carbamate.
The CAS Registry Number is 43210-67-9.
The chemical structure is:
Each gram of Ozipco® Paste 10% contains 100 mg of fenbendazole and is flavored with artificial apple-cinnamon liquid.
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INDICATIONS:
Horses: Ozipco Paste 10% is indicated for the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), encysted early 3rd stage (hypobiotic), late 3rd stage and 4th stage cyathostome larvae, small strongyles, pinworms (Oxyuris equi), ascarids (Parascaris equorum), and for the control of arteritis caused by 4th stage larvae of Strongylus vulgaris in horses.
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PRECAUTIONS:
Horses: Side effects associated with Ozipco Paste 10% could not be established in well-controlled safety studies in horses using single doses as high as 45 mg/lb (100 mg/kg) and 5 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly with higher doses, the release of antigen following parasite death may result in either a local or systemic hypersensitivity reaction. As with any drug, these reactions should be treated symptomatically. Ozipco Paste 10% has been evaluated for safety in pregnant mares during all stages of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in stallions with doses as high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproduction were detected. The recommended dose for control of 4th stage Strongylus vulgaris larvae, 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days, has not been evaluated for safety in stallions or pregnant mares.
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DOSAGE:
For foals and weanlings (less than 18 months of age) where ascarids are a common problem, the recommended dose is 4.6 mg/lb (10 mg/kg); one syringe will deworm a 550 lb horse. For the control of large strongyles, small strongyles, and pinworms, the recommended dose is 2.3 mg/lb (5 mg/kg). For control of hypobiotic (encysted early 3rd stage), late 3rd stage, and 4th stage cyathostomum larvae, 5 day treatment is recommended (10 mg/kg daily for 5 consecutive days); administer one syringe for each 550 lb body weight per day. Do not underdose. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
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WARNINGS
WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-929-822-0639. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.
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SPL UNCLASSIFIED SECTION
OTHER WARNINGS: Do not use in horses intended for human consumption. Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with pasture management practices appropriate to the geographic area and animals on the premises may reduce the potential for parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
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DIRECTIONS FOR USE:
- Determine the weight of the horse.
- Remove syringe tip.
- Turn the dial ring until the edge of the ring nearest the tip lines up with the correct weight marking.
- Depress plunger to advance paste to tip.
- Set the dial ring at the graduation nearest the weight of the horse for the dosage rate of 5 mg/kg. For the dosage rate of 10 mg/kg, set the dial ring at two times (double) the horse’s weight.
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Body Weight Number of marks for 2.3 mg/lb (5 mg/kg) dose for cattle or horses Number of marks for 4.6 mg/lb (10 mg/kg) dose for horses only 250 lb 1 2 500 lb 2 4 750 lb 3 6 1000 lb 4 8 1500 lb 6 12 - Horse’s mouth should be free of food.
- Insert nozzle of syringe through the interdental space and deposit the paste on the back of the tongue by depressing the plunger.
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INGREDIENTS AND APPEARANCE
OZIPCO
fenbendazole pasteProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC: 86241-101 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 g Product Characteristics Color Score Shape Size Flavor APPLE, CINNAMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 86241-101-01 1 in 1 CARTON 1 25 g in 1 SYRINGE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA120648 05/15/2020 Labeler - Fast Sold LLC (123898597) Registrant - Fast Sold LLC (123898597) Establishment Name Address ID/FEI Business Operations Zhejiang Hisun Pharmaceutical Co., Ltd. 654211754 api manufacture
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