Safe-Guard

Manufacturer
Merck Sharp & Dohme Corp. | ADM Alliance Nutrition, Inc.
Effective date
2024-11-19
Label type
OTC ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:43:54

Label at a glance#

ProductSafe-Guard
Active ingredientFENBENDAZOLE
Label structure31 sections

Dosage and administration

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.

Storage and handling

STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CATTLE: Dairy and Beef Cattle

SWINE: Growing pigs, gilts, pregnant sows and boars

HORSES

Zoo and Wildlife Animals

Growing Turkeys

Wild Quail

MUST BE MIXED BEFORE FEEDING ACCORDING TO DIRECTIONS AND PERMITTED CLAIMS.
FOR USE IN MANUFACTURED FEEDS ONLY.

SPL UNCLASSIFIED SECTION

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.

VETERINARY INDICATIONS SECTION

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).

DRUG FEEDING RATE:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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 FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
11.041,001 (0.5)
195.5917,740 (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 FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
2.20200 (0.1)
11.021,000 (0.5)

FEEDING DIRECTIONS:

SPL UNCLASSIFIED SECTION

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.

WARNINGS SECTION

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 www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

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.

RESIDUE WARNING SECTION

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.

VETERINARY INDICATIONS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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 FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
11.031,000 (0.5)
195.5917,740 (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 FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
0.1110 (0.005)
3.31300 (0.15)

FEEDING DIRECTIONS:

SPL UNCLASSIFIED SECTION

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.

WARNINGS SECTION

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 www.fda.gov/reportanimalae.

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.

SPL UNCLASSIFIED SECTION

Withdrawal Periods: Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product.

HORSES

VETERINARY INDICATIONS SECTION

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).

DRUG FEEDING RATE:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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 FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
110.2510,000 (5.0)
195.5917,740 (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 FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
50.054,540 (2.27)

FEEDING DIRECTIONS:

SPL UNCLASSIFIED SECTION

No prior withdrawal of feed or water necessary. Type C medicated horse feed containing SAFE-GUARD® 20% can also be fed pelleted.

WARNINGS SECTION

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 www.fda.gov/reportanimalae.

RESIDUE WARNING SECTION

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

Approved by FDA under NADA # 131-675

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

STORAGE AND HANDLING SECTION

STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.

SPL UNCLASSIFIED SECTION

SEE OTHER SIDE FOR ZOO AND WILDLIFE ANIMALS, GROWING TURKEYS AND WILD QUAIL.

Net Weight 25 pounds (11.34 kg)

Lot/Expiration date located below:

797217 R2

Zoo and Wildlife Animals

VETERINARY INDICATIONS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

Host AnimalRecommended Treatment Formg 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)
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)

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
Down ArrowDown Arrow
Down ArrowDown Arrow

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:

SPL UNCLASSIFIED SECTION

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 FeedResulting Fenbendazole Concentration in Type C Medicated Feed
[grams/ton (grams/pound)]
0.5550 (0.025)
11.021,000 (0.5)

FEEDING DIRECTIONS:

SPL UNCLASSIFIED SECTION

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.

WARNINGS SECTION

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 www.fda.gov/reportanimalae.

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 SECTION

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

Growing Turkeys

VETERINARY INDICATIONS SECTION

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).

DRUG FEEDING RATE:

DOSAGE & ADMINISTRATION SECTION

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

MIXING DIRECTIONS:

SPL UNCLASSIFIED SECTION

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 FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
5.51500 (0.25)
195.5917,740 (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 FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
0.1614.5 (0.007)

FEEDING DIRECTIONS:

SPL UNCLASSIFIED SECTION

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 SECTION

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 www.fda.gov/reportanimalae.

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 SECTION

Withdrawal Periods: No withdrawal period is required when used according to labeling.

Wild Quail

VETERINARY INDICATIONS SECTION

FOR THE TREATMENT AND CONTROL OF:

Gastrointestinal worms: Cecal worms, (Aulonocephalus spp.)

DRUG FEEDING RATE:

DOSAGE & ADMINISTRATION SECTION

90.7 g fenbendazole/ton of feed, to be fed for 21 days.

MIXING DIRECTIONS:

SPL UNCLASSIFIED SECTION

Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated Wild Quail 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 medications can be prepared:

Wild Quail Type B Medicated Feed Instructions
Pounds of Type A Medicated Article to Add per Ton of Feed to Make a Type B Medicated FeedResulting Fenbendazole Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
11.041,001 (0.50)
195.5917,740 (8.9)

Thoroughly mix SAFE-GUARD® 20% Type A medicated article with non-medicated Wild Quail 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:

Wild Quail Type C Medicated Feed Instructions
Pounds of Type A Medicated Article to Add per Ton to Make a Type C Medicated FeedResulting Fenbendazole Concentration in Type C Medicated Feed [grams/ton (grams/pound)]
1.090.7 (0.05)

FEEDING DIRECTIONS:

SPL UNCLASSIFIED SECTION

Medicated feed should be fed for 21 consecutive days to wild quail. No prior withdrawal of feed is necessary. It is recommended that wild quail feed containing SAFE-GUARD® be fed as crumbles. It is not recommended that medicated feed containing fenbendazole be generally broadcast, but rather offered in strategic feeding stations or through feeders. Users should ensure that the medicated feed is consistently available during the 21-day treatment period.

WARNINGS SECTION

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 www.fda.gov/reportanimalae.

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 SECTION

Withdrawal Periods: No withdrawal period is required when used according to labeling.

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

STORE AT OR BELOW 25°C (77°F). EXCURSIONS UP TO 40°C (104°F) ARE PERMITTED.

SPL UNCLASSIFIED SECTION

SEE OTHER SIDE FOR CATTLE, SWINE, AND HORSES.

Net Weight 25 pounds (11.34 kg)

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 131-675

MERCK
Animal Health

Distributed by:
Intervet Inc. (d/b/a Merck Animal Health)
Rahway, NJ 07065

Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA
and its affiliates. All rights reserved.

Rev. 10/2023

PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Wild Quail

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.

PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label
PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57926-090-25Safe-Guard11.34 kg in 1 BAGPOWDER11.345
57926-090-25Safe-Guard1 in 1 BAGPOWDER15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57926-090SAFE-GUARD (FENBENDAZOLE) POWDER [MERCK SHARP & DOHME CORP.]52 package rows20241121_e1bb5aa8-3316-47f1-be79-cdbcd62b7222.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FenbendazoleACTIVE INGREDIENT621BVT9M361
FenbendazoleACTIVE MOIETY621BVT9M361
Calcium CarbonateINACTIVE INGREDIENTH0G9379FGK1
Mineral OilINACTIVE INGREDIENTT5L8T28FGP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57926-09057926-090-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
FENBENDAZOLE621BVT9M36ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
Calcium CarbonateCALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.