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Animal NDC 66283-085-47 Safe-guard

Fenbendazole

Animal Product Information

Field Name Field Value
Animal NDC Code 66283-085-47
Proprietary Name Safe-guard What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Fenbendazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Intervet Production S.a.
Product Type Otc Animal Drug
Usage Information
    INDICATIONS:Safe‑Guard® 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.
Active Ingredient(s)
  • Fenbendazole
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA132872 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Safe-guard Images

Safe-guard Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Paste 10% (100 mg/g) Equine Dewormer

Fenbendazole (active ingred.) made in: see imprint. Formulated in France.

Distributed by:
Intervet Inc. (d/b/a Merck Animal Health)
Rahway, NJ 07065

Approved by FDA under NADA # 120-648

©2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.

Rev. 07/23


Description



DESCRIPTION:

Safe-Guard® (fenbendazole) Paste 10% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole carbamate.

The chemical structure is:

Each gram of Safe-Guard® Paste 10% contains 100 mg of fenbendazole and is flavored with artificial apple-cinnamon liquid.


Mechanism Of Action



ACTIONS:

The antiparasitic action of Safe‑Guard® Paste 10% is believed to be due to the inhibition of energy metabolism in the parasite.


Indications & Usage



INDICATIONS:

Safe‑Guard® 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.


Precautions



PRECAUTIONS:

Side effects associated with Safe‑Guard® Paste 10% could not be established in well-controlled safety studies in horses with single doses as high as 454 mg/lb (1,000 mg/kg) and 15 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly with higher doses, the lethal action of fenbendazole may cause the release of antigens by the dying parasites. This phenomenon may result in either a local or systemic hypersensitivity reaction. As with any drug, these reactions should be treated symptomatically. Safe‑Guard® 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.


Warnings



WARNING: 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 1-800‑211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1‑888-FDAVETS, or http://www.fda.gov/reportanimalae.


Food Safety Warning



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 parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of 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 the 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 a 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.


Dosage Forms & Strengths



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 cyathostome larvae, 4th stage Strongylus vulgaris larvae, the recommended dose is 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days; administer one syringe for each 550 lb body weight per day.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.


Dosage & Administration



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 zero.
  • 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.
  • 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.

    • CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT AND CONTROL OF PARASITISM.


How Supplied



HOW SUPPLIED:

Safe‑Guard® Paste 10% Equine Dewormer is supplied in 25 gram syringes.


Storage And Handling



Store at or below 25°C (77°F).

Use Only as Directed


Principal Display Panel - 25 Gram Syringe Carton



MERCK
Animal Health

safe-guard®
(fenbendazole)

Equine
Dewormer

25 gram Paste 10%
(100 mg/g)

MERCK
Animal Health


Principal Display Panel - 92 G Syringe Carton



safe-guard®
(fenbendazole)

Dewormer
for Beef & Dairy Cattle and Horses
92 g Paste 10% (100 mg/g)

One syringe deworms 4 (1,000 lb) cattle or 4 (1,000 lb)
horses at a dose of 5 mg/kg or 4 (500 lb) horses
at a dose of 10 mg/kg to treat ascarid infections.

Net Weight 92 g (3.2 oz)

MERCK
Animal Health


Principal Display Panel - 290 G Tube Carton



safe-guard®
(fenbendazole)

Net Weight 290 g (10.2 oz)

Dewormer
for Beef & Dairy Cattle
290 g Paste 10% (100 mg/g)

One tube deworms 12 (1,000 lb) cattle
or 58 animals of 220 lb each.

To be used only with Safe-Guard® dosing equipment.

MERCK
Animal Health


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.