Otc - Active Ingredient
Febendazole
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Zhenshangzekai Technology Co., Ltd. for the product Fenbendazole Oral Dewormer (NDC 87276-263). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - keep out of reach of children, other safety information, dosage & administration, otc - purpose, warnings, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Febendazole
Glycerin, Magnesium Aluminum Silicate, Sodium Carboxymethylcellulose, Sorbitol, and Purified
Water.
Keep out of the reach of children.
The antiparasitic efficacy is achieved through the systematic inhibition of energy metabolism
within the target parasites.
Standard Therapeutic Dose:
2.3 mg/lb(5 mg/kg) of body weight.
Intensive Care Dose:
4.6 mg/lb(10 mg/kg) for specific larval stages or young animals.
Calibration Instructions:
1.Accurately assess the animal's weight prior to administration.
2. Remove the protective tip and rotate the dial ring to the zero position.
3. Advance the dial ring to the graduation corresponding to the measured weight.
4. Ensure the oral cavity is clear of food particles.
5. Administer the paste onto the back of the tongue by depressing the plunger firmly.
Yield: One 25g syringe provides a complete dose for a 1,100 lb animal at the standard 5 mg/kg
rate.
dewormer
Human Safety: NOT FOR USE IN HUMANS.
· Food Safety: Do not use in animals intended for human consumption.
· Animal Care: Safety in pregnant animals or breeding stallions at the 10 mg/kg dosage for 5
days has not been specifically evaluated.
· Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
Resistance Management:
Fecal examinations and diagnostic monitoring are recommended to maintain long-term efficacy
and manage parasite resistance.
Environmental & Storage Conditions:
· Store at or below 25°C (77℉) in a temperature-controlled environment.
· Keep the syringe tightly capped when not in use.
Indicated for the clinical management of:
Large Strongyles: (Strongylus edentatus, S. equinus, S. vulgaris).
Small Strongyles: Including various larval stages (encysted early 3rd stage, late 3rd stage, and 4th
stage cyathostome larvae).
Ascarids / Roundworms: (Parascaris equorum).
Pinworms: (Oxyuris equi).
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