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Animal NDC 58005-105-07 Neomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 58005-105-07
Proprietary Name Neomycin 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 Neomycin 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 Sparhawk Laboratories, Inc.
Product Type Prescription Animal Drug
Usage Information
    Neomycin SulfateAntibacterialFOR ANIMAL USE ONLYKEEP OUT OF REACH OF CHILDRENIndicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycinCAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian.Restricted Drug-Use Only As Directed (California)For Oral Use in Animals only.Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.ANADA#: 200-379 Approved by F.D.A.
Active Ingredient(s)
  • Neomycin Sulfate
Marketing Category ANADA - ABBREVIATED 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 ANADA200379 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.

Neomycin Images

Neomycin 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



Indications & Usage



Neomycin Sulfate

Antibacterial

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.

Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycin

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

Restricted Drug-Use Only As Directed (California)

For Oral Use in Animals only.

Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.

ANADA#: 200-379 Approved by F.D.A.


Dosage And Administration



Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days.

       Dosage Schedule for treatment of colibacillosis:

   Pounds of                               Amount of Neomycin Liquid

 Body Weight                              Per Day in Divided Doses  

      25 lbs                                           1/4 teaspoonful
      50 lbs                                           1/2 teaspoonful
    100 lbs                                            1 teaspoonful
    300 lbs                                            1 tablespoonful
    600 lbs                                            1 fluid ounce

Teaspoon = U.S. Standard Measure

Neomycin Liquid may be given undiluted or diluted with water.

Herd Treatment: Each bottle will treat 9,600 pounds body weight. Therefore, estimate the total number of pounds body weight of the animals to be treated and administer on (1) fluid ounce for each 600 pounds. The product should be added to the amount of drinking water to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.

Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) teaspoon in water or milk for each 100 pounds body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.


Precautions



To administer the stated dosage, the concentration of neomycin required in medicated water must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption.


General Precautions



If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. If symptoms such as fever, depression, or going off feed develop, oral neomycin is not indicated as the sole treatment since systemic levels of neomycin are not obtained due to low absorption from the gastrointestinal tract.

Important: Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Animals not drinking or eating should be treated individually by drench.


Warnings



Not for human use. Keep out of reach of children. Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:

   Cattle .............................................. 1 day

   Sheep ............................................ 2 days

   Swine and Goats ............................. 3 days

Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues. 

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.


Storage And Handling



Store at controlled room temperature 20o to 25oC (68o to 77oF) (see USP)

TAKE TIME OBSERVE LABEL DIRECTIONS


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