Animal NDC 57926-089-01 Safe-guard
Fenbendazole

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-089-01
Proprietary Name Safe-guard What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Fenbendazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Schering Corporation
Product Type Otc Animal Drug
Active Ingredient(s)
  • Fenbendazole
Inactive Ingredient(s)
  • METHYLPARABEN (A2I8C7HI9T)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • SILICON DIOXIDE (ETJ7Z6XBU4)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (K679OBS311)
  • POVIDONE, UNSPECIFIED (FZ989GH94E)
  • TRISODIUM CITRATE DIHYDRATE (B22547B95K)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • WATER (059QF0KO0R)
  • METHYLPARABEN (A2I8C7HI9T)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • SILICON DIOXIDE (ETJ7Z6XBU4)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (K679OBS311)
  • POVIDONE, UNSPECIFIED (FZ989GH94E)
  • TRISODIUM CITRATE DIHYDRATE (B22547B95K)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • WATER (059QF0KO0R)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA128620 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Safe-guard Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Goats - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of:

Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.

Distributed by: Intervet Inc
(d/b/a Merck Animal Health)

Madison, NJ 07940 ©2020 Intervet Inc.,
a subsidiary of Merck & Co. Inc.

LOT NO:

EXP
DATE:

Rev. 09/20

Approved by FDA under
NADA # 128-620

387770 R11


Dosage & Administration



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

Dosing Examples for Goats:

Body WeightAmount
25 lb0.6 mL
50 lb1.2 mL
75 lb1.7 mL
100 lb2.3 mL
125 lb2.9 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.

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


Warnings



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.


Storage And Handling



Store at or below 25°C (77°F). Protect from freezing. Shake well before use.

Restricted drug (California) - Use only as directed.


Principal Display Panel - 125 Ml Bottle Label



safe-guard®
(fenbendazole)

Dewormer
for Goats

Suspension 10%
(100mg/mL)

Withdrawal Periods and Residue
Warnings: Goats must not be
slaughtered for human consumption
within 6 days following treatment.
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.

MERCK
Animal Health

125 mL (4.2 fl oz)

368607 R6


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.