SAFE-GUARD- fenbendazole powder

Safe-Guard by

Drug Labeling and Warnings

Safe-Guard by is a Animal medication manufactured, distributed, or labeled by Schering Corporation, ADM Alliance Nutrition, Inc., Intervet Mexico S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 or Soybean Oil.

CATTLE

Dairy and Beef Cattle

FOR THE REMOVAL AND CONTROL OF:

Lungworms: (Dictyocaulus viviparus).

Stomach worms: Barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei).

Intestinal worms: Hookworms (Bunostomum phlebotomum), threadnecked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora).

Bankrupt worms: (Trichostrongylus colubriformis).

Nodular worms: (Oesophagostomum radiatum).

DOSAGE REGIMEN

5 mg fenbendazole per kg body weight in a one (1) day treatment (2.27 mg fenbendazole per pound).

EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE

For a one (1) day treatment, mix the following quantities of SAFE-GUARD® 20% Type A Medicated Article into the daily ration according to body weight and number of cattle per pen.

Amount of SAFE-GUARD® 20% Type A Medicated Article for:

Body Weight		10 Cattle		20 Cattle		100 Cattle
lbs.	kg	g	lbs.	g	lbs.	g	lbs.
200	90.7	23	0.05	46	0.10	230	0.5
400	181.4	46	0.10	92	0.20	460	1.0
600	272.2	69	0.15	138	0.30	690	1.5
800	362.9	92	0.20	184	0.40	920	2.0
1000	453.6	114	0.25	228	0.50	1140	2.5
1400	635.0	160	0.35	320	0.70	1600	3.5

Feed as the sole ration for one (1) day. No prior withdrawal of feed or water necessary. When feed containing SAFE-GUARD® has been fed for 1 day and blended according to the above rates based on weight and number of cattle treated, a total intake of 2.27 mg fenbendazole per pound of body weight is assured. Cattle feed containing SAFE-GUARD® can be fed pelleted or as meal.

FREE-CHOICE FEEDS

Free-choice feed must be formulated to provide a total of 5 mg per kg body weight over 3 to 6 days. (Only a licensed medicated feed mill may manufacture the dry or liquid free choice feeds following the approved formulas.)

Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks.

GENERAL USE DIRECTIONS

It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.

CAUTION

Due to the possible variation in animal feeding behavior, underdosing may occur in individual animals. Underdosing may encourage the development of parasite resistance. It is recommended that parasite resistance be monitored following the use of any anthelmintic with the use of a fecal egg count reduction test program.

WARNING

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

RESIDUE WARNING

Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle, the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

SWINE

Growing pigs, gilts, pregnant sows, and boars

FOR THE REMOVAL AND CONTROL OF:

Lungworms: (Metastrongylus apri, Metastrongylus pudendotectus).

Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); whipworms, adult and larvae (L2, L3, L4 stages - intestinal mucosal forms) (Trichuris suis).

Kidney worms: Adult and larvae (Stephanurus dentatus).

DOSAGE REGIMEN

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.

EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE

Average daily feed consumption		Amount of SAFE-GUARD® 20% Type A Medicated Article added to each ton of swine feed based on weight and average feed consumption
		Treatment Period
Pig Wt. (lbs.)	lbs. of Feed	3 Days		6 Days		12 Days
		lbs.	Grams	lbs.	Grams	lbs.	Grams
30	2.25	0.40	182	0.20	91	0.10	46
50	3.20	0.47	213	0.24	107	0.12	54
75	4.25	0.53	241	0.27	121	0.14	61
100	5.30	0.57	258	0.29	129	0.15	65
150	6.80	0.66	301	0.33	151	0.17	76
200	8.00	0.75	341	0.38	171	0.19	86

Feed as the sole ration for three (3) to twelve (12) consecutive days. No prior withdrawal of feed or water necessary. When feed containing SAFE-GUARD® has been blended according to the above rates based on pig weight and average daily feed consumption, and is then fed for 3-12 days, a total intake of 9 mg fenbendazole per kilogram body weight (4.08 mg fenbendazole per pound) is assured. Swine feeds containing SAFE-GUARD® can be fed pelleted or as meal.

GENERAL USE DIRECTIONS

It is recommended that SAFE-GUARD® 20%Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20%Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20%Type A Medicated Article.

WARNING

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

RESIDUE WARNING

There is no pre-slaughter withdrawal period as SAFE-GUARD® can be fed to day of slaughter.

HORSES

FOR THE 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)

DOSAGE REGIMEN

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.

EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE

For a ONE (1) DAY treatment, mix the following quantities of SAFE-GUARD® 20% Type A Medicated Article into the daily ration according to body weight and dose.

Amount of SAFE-GUARD® 20% Type A Medicated Article
Body Weight	For dose of 2.27 mg fenbendazole/lb body weight	For dose of 4.54 mg fenbendazole/lb body weight
lbs.	grams	grams
200	2.27	4.54
400	4.54	9.08
600	6.81	13.62
800	9.08	18.16
1000	11.35	22.70
1200	13.62	27.24

Feed for ONE (1) DAY as above. No prior withdrawal of feed or water is necessary. Horse feed containing SAFE-GUARD® 20% can be fed pelleted or as a meal.

Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection.

GENERAL USE DIRECTIONS

It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.

ANIMAL SAFETY

There are no known contraindications for the use of fenbendazole in horses. Side effects associated with SAFE-GUARD® 20% (fenbendazole) 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).

SAFE-GUARD® 20% (fenbendazole) 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.

WARNING

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

RESIDUE WARNING

Do not use in horses intended for human consumption.

Zoo and Wildlife Animals

FOR THE REMOVAL AND CONTROL OF

Internal parasites in hoofed zoo and wildlife animals (see dosage section for specific parasites, animal species and required doses).

DOSE/DOSAGE REGIMENS

Host Animal	Recommended Treatment for	mg Fenbendazole/kg Body Wt./Day × Days of Treatment
Bighorn Sheep (Ovis canadensis canadensis)	lungworms: (Protostrongylus spp.)	10 mg × 3
Feral Swine; (Sus scrofa)	kidney worms: (Stephanurus dentatus),; roundworms: (Ascaris suum),; nodular worms: (Oesophagostomum dentatum)	3 mg × 3
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 × 3
Ruminants - subfamily; hippotraginae: Addax (Addax nasomasculatus); Angolan roan antelope; (Hippotragus equinus cottoni); Fringed-ear oryx (Oryx gazella 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.

GENERAL USE DIRECTIONS

SAFE-GUARD® 20% Type A Medicated Article must be mixed according to directions and at correct concentrations based upon the species to be treated. It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. The correct proportions of premix and feed ingredients should be established for blending into the complete feed. This premix and feed ingredient combination should be thoroughly and uniformly mixed with the complete feed.

SAFE-GUARD® 20% Type A Medicated Article can be fed to adult and young animals either in a mash or pelleted feed. No prior withdrawal of feed or water is necessary.

WARNING

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

ANIMAL SAFETY

No contraindications for the use of fenbendazole in a zoo environment have been established. Administration to breeding and pregnant ruminants at 2 to 22 times the recommended dose has had no apparent adverse effect.

RESIDUE WARNING

Do not use 14 days before or during the hunting season.

Growing Turkeys

FOR THE REMOVAL 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).

DOSAGE REGIMEN

14.5 g fenbendazole/ton of feed, to be fed as the sole ration for 6 days.

GENERAL USE DIRECTIONS

It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.

FEEDING DIRECTIONS

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. Growing turkey feeds containing SAFE-GUARD® can be fed pelleted or as meal.

WARNING

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. NOT FOR USE IN HUMANS. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance contact customer service at 1-800-441-8272.

RESIDUE WARNING

There is no pre-slaughter withdrawal period as SAFE-GUARD® can be fed to day of slaughter.

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING

STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.
SEE OTHER SIDE FOR CATTLE, SWINE AND HORSES.

SPL UNCLASSIFIED SECTION

Net Weight 25 pounds (11.34 kg)

Distributed by: Intervet Inc.
Millsboro, DE 19966

NADA # 131-675, Approved by FDA

PRINCIPAL DISPLAY PANEL - 11.34 kg Bag

Safe-Guard®
(fenbendazole)

Dewormer

20%Type A Medicated Article

INGREDIENTS AND APPEARANCE

SAFE-GUARD 
fenbendazole powder

Product 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	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Intervet Mexico S.A. de C.V.		588215863	API MANUFACTURE