SAFE-GUARD- fenbendazole suspension 
Merck Sharp & Dohme Corp.
Reference Label Set Id: 93c3abe2-5d4b-4d90-ac25-b2078026629e

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safe-guard®
(fenbendazole)
Dewormer

INDICATIONS: Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight 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 & 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).

Goats - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.

DIRECTIONS: Administer orally. The recommended dose of 2.3 mg/lb (5 mg/kg) of body weight is achieved when 2.3 mL of the drug are given for each 100 lb body weight.

EXAMPLES:

Cattle:Goats:
Body WeightAmountBody WeightAmount
100 lb2.3 mL25 lb0.6 mL
200 lb4.6 mL50 lb1.2 mL
300 lb6.9 mL75 lb1.7 mL
400 lb9.2 mL100 lb2.3 mL
500 lb11.5 mL125 lb2.9 mL
1000 lb23.0 mL
1500 lb34.5 mL

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.

WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. 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.

Store at or below 25°C (77°F).
Protect from freezing. Shake well before use.
Restricted drug (California) – use only as directed.

Fenbendazole (active ingred.) made in China. Formulated in France.

Distributed by: Intervet Inc (d/b/a Merck Animal Health), Madison, NJ 07940

Approved by FDA under NADA # 128-620
©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
Rev. 09/20

367235 R3

PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label

safe-guard®
(fenbendazole)

Dewormer

for Beef & Dairy Cattle
and Goats

Suspension 10%
(100 mg/mL)

Withdrawal Periods and Residue Warnings: Milk
taken from cows during treatment and for 48 hours
after the last treatment must not be used for human
consumption. Cattle must not be slaughtered for
human consumption within 8 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.

Goats must not be slaughtered for human consumption
within 6 days following last treatment with this drug
product. Because a milk discard time has not been
established, do not use in lactating goats.

Consult your veterinarian for assistance in the diagnosis,
treatment and control of parasitism.

LOT NUMBER:
EXPIRATION DATE:

1 Gallon (3,785 mL)

MERCK
Animal Health

386508 R4

PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label
SAFE-GUARD 
fenbendazole suspension
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-088
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
povidone, unspecified (UNII: FZ989GH94E)  
trisodium citrate dihydrate (UNII: B22547B95K)  
citric acid monohydrate (UNII: 2968PHW8QP)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57926-088-013785 mL in 1 BOTTLE
2NDC:57926-088-021000 mL in 1 BOTTLE
3NDC:57926-088-0310000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12862009/20/1983
Labeler - Merck Sharp & Dohme Corp. (001317601)
Establishment
NameAddressID/FEIBusiness Operations
Intervet Production S.A.771867553MANUFACTURE

Revised: 9/2021
Document Id: f5cae041-548d-49d8-8df0-76029db34a0d
Set id: 9188886a-54bc-4c68-9f1d-37a20e031076
Version: 4
Effective Time: 20210910
 
Merck Sharp & Dohme Corp.