Animal NDC 57926-090-25 Safe-guard
Fenbendazole
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 57926-090-25 |
| 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 | Schering Corporation |
| 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 | NADA131675 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 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
CATTLE: Dairy and Beef Cattle
SWINE: Growing pigs, gilts, pregnant sows and boars
HORSES
Zoo and Wildlife Animals
Growing Turkeys
MUST BE MIXED BEFORE FEEDING ACCORDING TO DIRECTIONS AND PERMITTED CLAIMS.
FOR USE IN MANUFACTURED FEEDS ONLY.
ACTIVE DRUG INGREDIENT: Fenbendazole 200 grams per kilogram (90.7 grams per pound).
INERT INGREDIENTS: Roughage Products or Roughage Products and Calcium Carbonate; and Mineral Oil.
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.
OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.
Withdrawal Periods: Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product.
Approved by FDA under NADA # 131-675
CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT, AND CONTROL OF PARASITISM.
SEE OTHER SIDE FOR ZOO AND WILDLIFE ANIMALS AND GROWING TURKEYS.
Net Weight 25 pounds (11.34 kg)
Lot / Expiration date located below:
364857 R15
OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.
OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.
SEE OTHER SIDE FOR CATTLE, SWINE, AND HORSES.
MERCK
Animal Health
Distributed by:
Intervet Inc. (d/b/a Merck Animal Health)
Madison, NJ 07940
©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
Madison, NJ 07940
Rev. 09/2020
Veterinary Indications
CATTLE: Dairy and Beef Cattle
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), fourth stage larvae barberpole worms (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).
SWINE: Growing pigs, gilts, pregnant sows, and boars
FOR THE TREATMENT AND CONTROL OF:
Lungworms: Adult Metastrongylus apri, adult Metastrongylus pudendotectus; Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum), Adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), Adult small stomach worms (Hyostrongylus rubidus), Adult and larvae (L2, L3, L4 stages - intestinal mucosal forms) whipworms (Trichuris suis); and Kidney worms: Adult and larvae Stephanurus dentatus.
Drug Feeding Rate:
5 mg fenbendazole per kg body weight in a one (1) day treatment (2.27 mg fenbendazole per pound).
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.
9 mg fenbendazole per kg body weight (4.08 mg fenbendazole per pound) to be fed as the sole ration over a period of 3 to 12 days.
For the control of large strongyles, small strongyles, and pinworms the recommended dose is 5 mg fenbendazole per kg body weight (2.27 mg fenbendazole per pound) in a one (1) day treatment. For the control of ascarids the recommended dose is 10 mg fenbendazole per kg body weight (4.54 mg fenbendazole per pound) in a one (1) day treatment.
All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed.
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.
14.5 g fenbendazole/ton of feed, to be fed as the sole ration for 6 days.
Mixing Directions:
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated cattle feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:
| Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed | Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 11.04 | 1,001 (0.5) |
| 195.59 | 17,740 (8.9) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated cattle feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.
The following table gives examples of how some complete Type C medicated feeds can be prepared:
| Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed | Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 2.20 | 200 (0.1) |
| 11.02 | 1,000 (0.5) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:
| Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed | Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 11.03 | 1,000 (0.5) |
| 195.59 | 17,740 (8.9) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.
The following table gives examples of how some complete Type C medicated feeds can be prepared:
| Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed | Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 0.11 | 10 (0.005) |
| 3.31 | 300 (0.15) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated horse feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:
| Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed | Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 110.25 | 10,000 (5.0) |
| 195.59 | 17,740 (8.9) |
Thoroughly mix SAFE-GUARD® Type A medicated article with equine feed according to the table below to obtain the proper concentration in the Type C medicated feed:
| Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed | Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 50.05 | 4,540 (2.27) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated zoo/wildlife animal feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.
The following table gives examples of how some complete Type C medicated feeds can be prepared:
| Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed | Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 0.55 | 50 (0.025) |
| 11.02 | 1,000 (0.5) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated turkey feed according to the table below to obtain the proper concentration in the Type B medicated feed. The following table gives an example of how some Type B medicated feed concentrations can be prepared:
| Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated Feed | Resulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 5.51 | 500 (0.25) |
| 195.59 | 17,740 (8.9) |
Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated growing turkey feed according to the table below to obtain the proper concentration in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients (a dilution of one part Type A medicated article and nine parts grain carrier is suggested), then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.
The following table describes how to obtain the proper concentration in the complete Type C medicated feed:
| Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated Feed | Resulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)] |
|---|---|
| 0.16 | 14.5 (0.007) |
Feeding Directions:
Feed as the sole ration for one (1) day. No prior withdrawal of feed or water necessary. Type C medicated cattle feeds containing SAFE-GUARD® 20% can be fed pelleted or as a meal.
FREE-CHOICE FEEDS: Type C free-choice medicated feed must be manufactured by a licensed feed mill according to an approved formula to provide a total of 5 mg per kg body weight fenbendazole over 3 to 6 days.
Feed as the sole ration for three (3) to twelve (12) consecutive days. No prior withdrawal of feed or water necessary.
Type C medicated swine feeds containing SAFE-GUARD® 20% can be fed pelleted or as a meal.
No prior withdrawal of feed or water necessary. Type C medicated horse feed containing SAFE-GUARD® 20% can also be fed pelleted.
Type C medicated feeds containing SAFE-GUARD®20% can be fed in either a mash or pelleted form. No prior withdrawal of feed or water is necessary.
Medicated feed containing fenbendazole should be fed as the sole ration for six (6) consecutive days to growing turkeys only. No prior withdrawal of feed or water necessary. Type C medicated growing turkey feeds containing SAFE-GUARD® 20% can be fed pelleted or as a meal.
Warnings
WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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.
WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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.
WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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.
WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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.
WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. 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.
Residue Warning
Withdrawal Periods and Residue Warnings: Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 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.
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.
Do not use in horses intended for human consumption.
RESIDUE WARNING: Do not use 14 days before or during the hunting season.
Withdrawal Periods: No withdrawal period is required when used according to labeling.
Horses
FOR THE TREATMENT AND CONTROL OF:
Large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), Small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), Pinworms (Oxyuris equi), Ascarids (Parascaris equorum).
Storage And Handling
STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.
Zoo And Wildlife Animals
FOR THE TREATMENT AND CONTROL OF:
Internal parasites in hoofed zoo and wildlife animals (see dosage section for specific parasites, animal species and required doses).
Drug Feeding Rates:
| Host Animal | Recommended Treatment For | mg Fenbendazole/kg Body Wt./Day × Days of Treatment |
|---|---|---|
| Bighorn sheep (Ovis canadensis canadensis) | Lungworms: (Protostrongylus spp.) | 10 mg/kg/day × 3 days |
| Feral swine (Sus scrofa) | Kidney worms: (Stephanurus dentatus), Roundworms:(Ascaris suum), Nodular worms: (Oesophagostomum dentatum) | 3 mg/kg/day × 3 days |
| Ruminants – subfamily antilopinae: Persian gazelles (Gazella subgutturosa subgutturosa) Addra gazelle (Gazella dama ruficollis) Slendorhorn gazelle (Gazella leptoceros) Kenya impala (Aepyceros melampus rendilis) Roosevelt's gazelle (Gazella granti roosevelti) Indian blackbuck (Antilope cervicapra) Mhorr gazelle (Gazella dama mhorr) Thomson's gazelles (Gazella thomsoni thomsoni) | Small stomach worms: (Trichostrongylus spp.), Thread-necked intestinal worms: (Nematodirus spp.), Barberpole worms: (Haemonchus spp.), Whipworms: (Trichuris spp.) | 2.5 mg/kg/day × 3 days |
| Ruminants – subfamily hippotraginae: Addax (Addax nasomaculatus) Angolan roan antelope (Hippotragus equinus cottoni) Fringed-ear oryx (Oryx gazelle callotis) Arabian oryx (Oryx leucoryx) | ||
| Ruminants – subfamily caprinae: Armenian mouflon (Ovis orientalis gmelini) Russian saiga (Saiga tatarica) |
It is recommended that the user exercise judgmental expertise as needed for retreatment within six (6) weeks. This would depend upon the conditions of continued exposure to parasites, condition of treated animals, and ambient temperatures.
Growing Turkeys
FOR THE TREATMENT AND CONTROL OF:
Gastrointestinal worms: Roundworms, Adults and larvae (Ascaridia dissimilis); Cecal worms, Adults and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead).
Principal Display Panel - 11.34 Kg Bag Label
TO OPEN-PULL NARROW TAPE
safe-guard®
(fenbendazole)
Dewormer
20% Type A
Medicated Article
CATTLE: Dairy and Beef Cattle
SWINE: Growing pigs, gilts, pregnant sows and boars
HORSES
Zoo and Wildlife Animals
Growing Turkeys
MUST BE MIXED BEFORE FEEDING ACCORDING TO DIRECTIONS AND PERMITTED CLAIMS.
FOR USE IN MANUFACTURED FEEDS ONLY.
ACTIVE DRUG INGREDIENT: Fenbendazole 200 grams per kilogram (90.7 grams per pound).
INERT INGREDIENTS: Roughage Products or Roughage Products and Calcium Carbonate; and Mineral Oil.
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.