NEO-TERRAMYCIN 100/100D- neomycin-oxytetracycline powder

Neo-Terramycin 100/100D by

Drug Labeling and Warnings

Neo-Terramycin 100/100D by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

(Antibiotic)

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

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONSUSE DIRECTIONS AND WARNINGSNADA #94-975, Approved by FDA8853000101-9076-08Net Weight 50 lb (22.7 kg)FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

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

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

NEO-TERRAMYCIN 100/100D 
neomycin-oxytetracycline powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-8853
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	100 g  in 0.45 kg
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	100 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-8853-0	22.7 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA094975	07/08/2009

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)