FDA.reportPublic FDA data

Neo-Oxy 100/100 MR

Manufacturer
Pharmgate Animal Health | Pharmgate Inc.
Effective date
2026-01-07
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:45:44

Label at a glance#

ProductNeo-Oxy 100/100 MR
Active ingredientOxytetracycline Hydrochloride, Neomycin Sulfate
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Neomycin
Oxytetracycline
Type A Medicated Article

SPL UNCLASSIFIED SECTION

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

DESCRIPTION SECTION

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

SPL UNCLASSIFIED SECTION

For Use in the Manufacture of Medicated Feeds

CAUTION: For Use in Dry Feeds ONLY.

NOT FOR USE IN LIQUID FEED SUPPLEMENTS

VETERINARY INDICATIONS SECTION

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*
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†
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

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

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

SPL UNCLASSIFIED SECTION

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 Timeeye logoeye logoObserve Directions

PRINCIPAL DISPLAY PANEL - 22.7 kg Drum Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

PRINCIPAL DISPLAY PANEL - 22.7 kg Drum Label
PRINCIPAL DISPLAY PANEL - 22.7 kg Drum Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51429-010-03Neo-Oxy 100/100 MR22.68 kg in 1 DRUMPOWDER22.686

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y6266931
Oxytetracycline HydrochlorideACTIVE INGREDIENT4U7K4N52ZM1
NeomycinACTIVE MOIETYI16QD7X2971
Oxytetracycline AnhydrousACTIVE MOIETYSLF0D9077S1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51429-01051429-010-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oxytetracycline Hydrochloride4U7K4N52ZMACTIB
Neomycin Sulfate057Y626693ACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.