Animal NDC 51429-010-03 Neo-oxy 100/100 Mr

Oxytetracycline Hydrochloride And Neomycin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 51429-010-03
Proprietary Name Neo-oxy 100/100 Mr 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 Oxytetracycline Hydrochloride And Neomycin 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 Pharmgate Animal Health
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    Mixing and Use DirectionsMix Neo-Oxy 100/100 MR® with non-medicated milk replacer to provide the following concentrations:INDICATIONS FOR USEUse Level of Oxytetracycline and Neomycinlbs. of Neo-Oxy 100/100 MR per ton of Type C Medicated FeedMixing directions are for example only and are based on mixing 1 lb of dry milk replacer with 1 gallon of water.Calves (milk replacer)For Calves (up to 250 lb): For treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible by neomycin. Feed continuously for 7-14 days in milk replacer or starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body weight/day20If calf weighs 100 lb, consuming 1 gallon of milk replacer per day.RESIDUE WARNING: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS. WITHDRAW 5 DAYS BEFORE SLAUGHTER. USE OF MORE THAN ONE PRODUCT CONTAINING NEOMYCIN OR FAILURE TO FOLLOW WITHDRAWAL TIMES MAY RESULT IN ILLEGAL DRUG RESIDUESCalves, Beef Cattle, and Nonlactating Dairy CattleFor treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible by neomycin. Feed continuously for 7-14 days in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body weight/day20RESIDUE WARNINGS: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS. WITHDRAW 5 DAYS BEFORE SLAUGHTER. USE OF MORE THAN ONE PRODUCT CONTAINING NEOMYCIN OR FAILURE TO FOLLOW WITHDRAWAL TIMES MAY RESULT IN ILLEGAL DRUG RESIDUESStore at or below 25°C (77°F) with excursions permitted to 37°C (98.6°F).Approved by FDA under NADA # 138-939
Active Ingredient(s)
  • Oxytetracycline Hydrochloride
  • Neomycin Sulfate
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 NADA138939 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-oxy 100/100 Mr 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



Neomycin
Oxytetracycline
Type A Medicated Article

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

For Use in the Manufacture of Medicated Feeds

CAUTION: For Use in Dry Feeds ONLY.

NOT FOR USE IN LIQUID FEED SUPPLEMENTS

Restricted Drug (California)
Use Only as Directed.
Not For Human Use.

Net Weight 50 lbs (22.7 kg)

Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, NE 68144

Take TimeObserve Directions


Description



Active Drug Ingredients:
Oxytetracycline Hydrochloride 100 grams/lb.
Neomycin Sulfate 100 grams/lb.


Veterinary Indications



Mixing and Use Directions
Mix Neo-Oxy 100/100 MR® with non-medicated milk replacer to provide the following concentrations:
INDICATIONS FOR USEUse Level of Oxytetracycline and Neomycinlbs. of Neo-Oxy 100/100 MR per ton of Type C Medicated Feed

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

Calves (milk replacer)
For Calves (up to 250 lb): For treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible by neomycin. Feed continuously for 7-14 days in milk replacer or starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body weight/day20

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

RESIDUE WARNING: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS. 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
Calves, Beef Cattle, and Nonlactating Dairy Cattle
For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible by neomycin. Feed continuously for 7-14 days in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.10 mg/lb body weight/day20
RESIDUE WARNINGS: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR USE IN PRERUMINATING CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL. A MILK DISCARD TIME HAS NOT BEEN ESTABLISHED FOR USE IN LACTATING DAIRY CATTLE. DO NOT USE IN FEMALE DAIRY CATTLE 20 MONTHS OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS. 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
Store at or below 25°C (77°F) with excursions permitted to 37°C (98.6°F).
Approved by FDA under NADA # 138-939

Principal Display Panel - 22.7 Kg Drum Label



Neo-Oxy 100/100 MR®

Neomycin
Oxytetracycline
Type A Medicated Article

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


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