Animal NDC 57926-088-03 Safe-guard
Fenbendazole
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 57926-088-03 |
| 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 | Merck Sharp & Dohme Corp. |
| Product Type | Otc Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| 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 | NADA128620 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. |
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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
Veterinary Indications
INDICATIONS: Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Lungworms: Adult Dictyocaulus viviparus; Stomach worms: Adult brown stomach worms (Ostertagia ostertagi), Adult and fourth stage larvae barberpole worms (Haemonchus contortus & H. placei), and Adult and fourth stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (Adult and fourth stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).
Other
Goats - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.
Fenbendazole (active ingred.) made in China. Formulated in France.
Distributed by: Intervet Inc (d/b/a Merck Animal Health), Madison, NJ 07940
Approved by FDA under NADA # 128-620
©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
Rev. 09/20
367235 R3
Dosage & Administration
DIRECTIONS: 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.
EXAMPLES:
| Cattle: | Goats: | |||
|---|---|---|---|---|
| Body Weight | Amount | Body Weight | Amount | |
| 100 lb | 2.3 mL | 25 lb | 0.6 mL | |
| 200 lb | 4.6 mL | 50 lb | 1.2 mL | |
| 300 lb | 6.9 mL | 75 lb | 1.7 mL | |
| 400 lb | 9.2 mL | 100 lb | 2.3 mL | |
| 500 lb | 11.5 mL | 125 lb | 2.9 mL | |
| 1000 lb | 23.0 mL | |||
| 1500 lb | 34.5 mL | |||
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.
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 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.
OTHER WARNINGS: 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.
Storage And Handling
Store at or below 25°C (77°F).
Protect from freezing. Shake well before use.
Restricted drug (California) – use only as directed.
Principal Display Panel - 3,785 Ml Bottle Label
safe-guard®
(fenbendazole)
Dewormer
for Beef & Dairy Cattle
and Goats
Suspension 10%
(100 mg/mL)
Withdrawal Periods and Residue Warnings: Milk
taken from cows during treatment and for 48 hours
after the last treatment must not be used for human
consumption. Cattle must not be slaughtered for
human consumption within 8 days following last
treatment with this drug product. Not for use in beef
calves less than 2 months of age, dairy calves, and
veal calves. A withdrawal period has not been
established for this product in pre-ruminating calves.
Goats must not be slaughtered for human consumption
within 6 days following last treatment with this drug
product. Because a milk discard time has not been
established, do not use in lactating goats.
Consult your veterinarian for assistance in the diagnosis,
treatment and control of parasitism.
LOT NUMBER:
EXPIRATION DATE:
1 Gallon (3,785 mL)
MERCK
Animal Health
386508 R4
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.