Animal NDC 0061-0134-01 Garasol

Gentamicin Sulfate

Animal Product Information

Field Name	Field Value
Animal NDC Code	0061-0134-01
Proprietary Name	Garasol 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	Gentamicin Sulfate 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	Merck Sharp & Dohme Corp.
Product Type	Otc Animal Drug
Usage Information	INDICATIONS Day-old chickens – GARASOL Injection is recommended for the prevention of early mortality associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate. Turkeys – As an aid in the prevention of early mortality of 1- to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.
Active Ingredient(s)	Gentamicin Sulfate
Inactive Ingredient(s)	WATER (059QF0KO0R) 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	NADA101862 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.

Garasol Images

PRINCIPAL DISPLAY PANEL - 100 mL Vial Label - garasol 01

Garasol 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.

Other
Description
Veterinary Indications
Residue Warning
How Supplied
Storage And Handling
Principal Display Panel - 100 Ml Vial Label

Other

Injection – 100 mg/mL
Anti-Infective for
Day-Old Chickens and
One- to Three-Day-Old
Turkeys

PRODUCT
INFORMATION

Approved by FDA under NADA # 101-862

CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian

CHEMISTRY Gentamicin is a bactericidal aminoglycoside antibiotic derived from Micromonospora purpurea of the Actinomycetes group. It is a powder, readily soluble in water and basic in nature. Gentamicin aqueous solutions do not require refrigeration and are stable overa wide range of temperatures and pH.

Chickens: Each day-old chicken should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2-mL dose. This concentration can be provided by diluting GARASOL Injection as follows:

GARASOL mL	Sterile Saline mL	# Doses	Dose/Chicken mL
1	99	500	0.2
2	198	1000	0.2
4	396	2000	0.2
10	990	5000	0.2
100 (1 bottle)	9900	50000	0.2

Turkeys: Each 1- to 3-day-old turkey should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 1 mg gentamicin in a 0.2-mL dose. The dose should be injected under the loose skin on top of the neck, halfway between the head and base of the neck. This concentration can be provided by diluting GARASOL Injection as follows:

GARASOL mL	Sterile Saline mL	# Doses	Dose/Turkey mL
1	19	100	0.2
2	38	200	0.2
4	76	400	0.2
10	190	1000	0.2
100 (1 bottle)	1900	10000	0.2

Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use.

Disinfect the injection site and top of the bottle with a suitable disinfectant, such as 70% isopropyl alcohol.

Use all precautions to prevent contamination of vial contents.

Intervet Inc. (d/b/a Merck Animal Health)
Madison, NJ 07940.

Formulated in Germany.

Rev. 03/2023

MERCK
Animal Health

165573 R1

Description

DESCRIPTION Each milliliter of GARASOL Injection contains 100 mg gentamicin base (equivalent to 156 mg gentamicin sulfate); 3.2 mg sodium bisulfite; 0.1 mg edetate disodium; 4.5 mg sodium acetate, anhydrous; 3.0 mg glacial acetic acid; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; water for injection q.s.

Veterinary Indications

INDICATIONS Day-old chickens – GARASOL Injection is recommended for the prevention of early mortality associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate. Turkeys – As an aid in the prevention of early mortality of 1- to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.

Residue Warning

Residue Warnings For use in day-old chickens and 1- to 3-day-old turkeys only. Chickens injected with GARASOL Injection must not be slaughtered for food for at least 5 weeks following treatment. Turkeys injected with GARASOL Injection must not be slaughtered for food for at least 9 weeks following treatment.

How Supplied

HOW SUPPLIED GARASOL Injection, 100 mg/mL, is available in 100-mL multiple-dose vials, NDC 0061-0134-01.

Storage And Handling

Store between 2° and 30°C (36° and 86°F). Use within 28 days of first puncture and puncture a maximum of 10 times.

Principal Display Panel - 100 Ml Vial Label

100 mg/mL

Sterile

Garasol^®
(gentamicin injection)
Injection

Caution: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian

(100 mL)

Approved by FDA under
NADA # 101-862