Animal NDC 23243-6755-3 Neo-sol 50
Neomycin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-6755-3
Proprietary Name Neo-sol 50 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 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 Huvepharma, Inc.
Product Type Prescription Animal Drug
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 ANADA200130 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-sol 50 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



100 Gram Packet Front Panel



Neo-Sol® 50
(neomycin sulfate soluble powder)

Antibacterial

For Oral Use in Cattle, Swine,
Sheep, Goats and Turkeys


Herd/Flock Treatment:



Each packet will treat 7150 pounds body weight. Therefore, estimate the total number
of pounds of body weight of the animals to be treated and administer one (1) packet
(or portion thereof) for each 7150 pounds. The product should be added to the amount
of drinking water estimated 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) level teaspoon in water or milk for each 160 pounds body weight. Administer
daily either as a drench in divided doses or in the drinking water to be consumed in
12 - 24 hours.

Drinking Water: Swine - Use the number of packets indicated below in 256 gallons of water,
or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.

Pigs weighing 25 to 50 lbs..... 2 packets
Pigs weighing 50 to 100 lbs... 3 packets
Pigs weighing over 100 lbs.... 4 packets

Each packet will treat 143,000 pounds body weight. Therefore, estimate the total number
of pounds of body weight of the animals to be treated and administer one (1) packet
(or portion thereof) for each 143,000 pounds. The product should be added to the amount
of drinking water estimated 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) level teaspoon in water or milk for each 160 pounds body weight. Administer
daily either as a drench in divided doses or in the drinking water to be consumed in
12 - 24 hours.

Drinking Water: Swine - Use the quantity indicated below in 5120 gallons of water,
or in 40 gallons of stock solution used in proportioner set to meter one ounce per gallon.

Pigs weighing 25 to 50 lbs..... 2 packets
Pigs weighing 50 to 100 lbs... 3 packets
Pigs weighing over 100 lbs.... 4 packets

Each packet will treat 35,750 pounds body weight. Therefore, estimate the total number of
pounds of body weight of the animals to be treated and administer one (1) packet (or portion
thereof) for each 35,750 pounds. The product should be added to the amount of drinking water
estimated 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)
level teaspoon in water or milk for each 160 pounds body weight. Administer daily either as a drench
in divided doses or in the drinking water to be consumed in 12-24 hours.

Drinking Water: Swine - Use the quantity indicated below in 1280 gallons of water, or in 10
gallons of stock solution used in proportioner set to meter one ounce per gallon.

Pigs weighing 25 to 50 lbs ........... 2 packets
Pigs weighing 50 to 100 lbs ......... 3 packets
Pigs weighing over 100 lbs .......... 4 packets


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.

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 for cattle, swine, sheep, goats, and 5
days for turkeys. Animals not drinking or eating should be treated individually by drench.

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.

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 for cattle, swine, sheep, goats, and 5
days for turkeys. Animals not drinking or eating should be treated individually by drench.


Residue Warnings:



Discontinue treatment prior to slaughter by at least the number of days listed below
for the appropriate species:

Turkeys ................... 0 days
Cattle ..................... 1 day
Sheep ..................... 2 days
Swine and goats ...... 3 days

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

Discontinue treatment prior to slaughter by at least the number of days listed below
for the appropriate species:

Turkeys ...................... 0 days
Cattle ........................ 1 day
Sheep ........................ 2 days
Swine and goats ......... 3 days

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

Discontinue treatment prior to slaughter by at least the number of days listed below for the
appropriate species:

Turkeys .................... 0 days
Cattle ...................... 1 day
Sheep ..................... 2 days
Swine and goats ......  3 days

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


2000 Gram Packet Front Panel



Neo-Sol® 50
(neomycin sulfate soluble powder)

Antibacterial

For Oral Use in Cattle, Swine,
Sheep, Goats and Turkeys


500 Gram Packet Front Panel



Neo-Sol® 50
(neomycin sulfate soluble powder)

Antibacterial

For Oral Use in Cattle, Swine,
Sheep, Goats and Turkeys


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