Safe-Guard Dewormer 20% Type A Medicated Article

Manufacturer: Intervet/Schering-Plough Animal Health

(fenbendazole)

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), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora).

Bankrupt Worms

(Trichostrongylus colubriformis).

Nodular Worms

(Oesophaogostomum 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.

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

General Mixing Directions

It is recommended that SAFE-GUARD^® 20% Type A Medicated Article be diluted before addition to the final 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 Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle, there is no milk withdrawal period.

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 Mixing Directions

It is recommended that SAFE-GUARD^® 20% Type A Medicated Article be diluted before addition to the final 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 Mixing 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 x Days Of Treatment
Bighorn Sheep (Ovis canadensis canadensis)	Lungworms (Protostrongylus spp.)	10 mg x 3
Feral Swine (Sus scrofa)	Kidney Worms (Stephanurus dentatus), Roundworms (Ascaris suum), Nodular Worms (Oesophagostomum dentatum)	3 mg x 3
Ruminants - Subfamily Antilopinae Persian gazelles (Gazella subgutturosa subgutturosa) Addra gazelle (Gazella dama ruficollis) Slenderhorn 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) 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)	Small Stomach Worms (Trichostrongylus spp.), Thread-necked Intestinal Worms (Nematodirus spp.), Barberpole Worms (Haemonchus spp.), Whipworms (Trichuris spp.)	2.5 mg x 3

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 Mixing 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 final 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.

Feeding Directions

Feed 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 SAFEGUARD^® can be fed pelleted or as meal.

General Mixing Directions

It is recommended that SAFE-GUARD^® 20% Type A Medicated Article be diluted before addition to the final 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.

Store At Or Below 25°c (77°f). Excursions Up To 40°c (104°f) Are Permitted.

Must Be Mixed Before Feeding According To Directions And Permitted Claims

For Use In Manufactured Feeds Only

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

Distributed by: Intervet Inc., Millsboro, DE 19966

NADA # 131-675, Approved by FDA

Net Weight
25 pounds (11.34 kg)	784628-A

Nac No.

11061803