Label: SAFE-GUARD- fenbendazole powder
- NDC Code(s): 57926-090-25
- Packager: Schering Corporation
- Category: OTC ANIMAL DRUG LABEL
Drug Label Information
Updated February 1, 2022
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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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).
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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.
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:
Cattle Type B Medicated Feed Instructions 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:
Cattle Type C Medicated Feed Instructions 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) 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.
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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.
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.
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.
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VETERINARY INDICATIONS
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.
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DRUG FEEDING RATE:
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.
MIXING DIRECTIONS:
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:
Swine Type B Medicated Feed Instructions 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:
Swine Type C Medicated Feed Instructions 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) -
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.
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.
- HORSES
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DRUG FEEDING RATE:
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.
MIXING DIRECTIONS:
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:
Equine Type B Medicated Feed Instructions 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:
Equine Type C Medicated Feed Instructions 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) -
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.
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.
- SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- Zoo and Wildlife Animals
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DRUG FEEDING RATES:
Host Animal Recommended Treatment For mg Fenbendazole/kg
Body Wt./Day
× Days of TreatmentBighorn 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.
MIXING DIRECTIONS:
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:
Feral Swine, Wildlife and Zoo Ruminants & Bighorn Sheep Type C Medicated Feed Instructions 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) - FEEDING DIRECTIONS:
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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.
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SPL UNCLASSIFIED SECTION
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.
- RESIDUE WARNING
- Growing Turkeys
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DRUG FEEDING RATE:
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 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:
Turkey Type B Medicated Feed Instructions 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:
Turkey Type C Medicated Feed Instructions 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) -
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.
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.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label
TO OPEN-PULL NARROW TAPE
safe-guard®
(fenbendazole)Dewormer
20% Type A
Medicated ArticleCATTLE: 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. -
INGREDIENTS AND APPEARANCE
SAFE-GUARD
fenbendazole powderProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57926-090 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole 200 g in 1 kg Inactive Ingredients Ingredient Name Strength Mineral Oil (UNII: T5L8T28FGP) Calcium Carbonate (UNII: H0G9379FGK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57926-090-25 1 in 1 BAG 1 11.34 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA131675 01/31/1984 Labeler - Schering Corporation (001317601) Establishment Name Address ID/FEI Business Operations ADM Alliance Nutrition, Inc. 834721284 MEDICATED ANIMAL FEED MANUFACTURE Establishment Name Address ID/FEI Business Operations Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. 420823163 API MANUFACTURE