Animal NDC 66104-8853-0 Neo-terramycin 100/100d

Neomycin-oxytetracycline

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-8853-0
Proprietary Name Neo-terramycin 100/100d 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-oxytetracycline 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 Phibro Animal Health
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    Mix Neo-Terramycin 100/100D with nonmedicated milk replacer to provide the following drug concentrations:Indications for UseOxytetracycline andNeomycin Amountlb. ofNeo-Terramycin 100/100D per ton1CALVES (milk replacer)For calves (up to 250 lb) for treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin10 mg/lb of body weight dailyFeed continuously for 7-14 daysTreatment should continue 24 to 48 hours beyond remission of disease symptoms.202CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLETreatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin10 mg/lb of body weight dailyFeed continuously for 7-14 daysTreatment should continue 24 to 48 hours beyond remission of disease symptoms.202WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. At the 10 mg/lb level, withdraw 5 days before slaughter.Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.A milk discard time has not been established for use in lactating dairy cattle.Do not use in female dairy cattle 20 months of age or older.1Mixing directions are for example only and are based on mixing 1 lb of dry milk replacer with 1 gallon of water.2If calf weighs 100 lb, consuming 1 gallon of milk replacer per day.
Active Ingredient(s)
  • Neomycin Sulfate
  • Oxytetracycline Hydrochloride
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • SODIUM ALUMINOSILICATE (058TS43PSM)
  • SUCROSE (C151H8M554)
  • MINERAL OIL (T5L8T28FGP)
  • SODIUM ALUMINOSILICATE (058TS43PSM)
  • SUCROSE (C151H8M554)
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 NADA094975 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.

Neo-terramycin 100/100d Images

Neo-terramycin 100/100d 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



Active Drug Ingredients:



Oxytetracycline (from oxytetracycline dihydrate)

equivalent to oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb

Neomycin Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb


Caution:



CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

CAUTION: For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.


Store In A Dry, Cool Place



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

NEO-TERRAMYCIN is a registered trademark of Pfizer, Inc

licensed to Phibro Animal Health Corporation for Neomycin-Oxytetracycline

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation of its affiliates.

Phibro Animal Health Corporation, Teaneck, NJ 07666


Mixing And Use Directions



Mix Neo-Terramycin 100/100D with nonmedicated milk replacer to provide the following drug concentrations:

Indications for Use

Oxytetracycline and

Neomycin Amount

lb. of

Neo-Terramycin 100/100D per ton1

CALVES (milk replacer)

For calves (up to 250 lb) for treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin

10 mg/lb of body weight daily

Feed continuously for 7-14 days

Treatment should continue 24 to 48 hours beyond remission of disease symptoms.

202

CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE

Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin

10 mg/lb of body weight daily

Feed continuously for 7-14 days

Treatment should continue 24 to 48 hours beyond remission of disease symptoms.

202

WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. At the 10 mg/lb level, withdraw 5 days before slaughter.

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

A milk discard time has not been established for use in lactating dairy cattle.

Do not use in female dairy cattle 20 months of age or older.

1Mixing directions are for example only and are based on mixing 1 lb of dry milk replacer with 1 gallon of water.

2If calf weighs 100 lb, consuming 1 gallon of milk replacer per day.


Indications & Usage



FOR USE IN ANIMAL FEEDS ONLY

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


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