Animal NDC 86108-012-10 Go-dry

Penicillin G Procaine In Sesame Oil

Animal Product Information

Field Name Field Value
Animal NDC Code 86108-012-10
Proprietary Name Go-dry 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 Penicillin G Procaine In Sesame Oil 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 Us Vet Inc
Product Type Prescription Animal Drug
Usage Information
    This product is intended for the treatment of bovine mastitis in dry cows. This product is effective against udder infections caused by the following susceptible microorganism: Streptococcus agalactiae.
Active Ingredient(s)
  • Penicillin G Procaine
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 NADA065081 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.

Go-dry 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



Description



Each syringe contains:
100,000 units of penicillin G procaine, sesame oil 8.7g, calcium carbonate 0.089g, corn starch 0.089g, hydrogenated castor oil 0.044g.


Indications



This product is intended for the treatment of bovine mastitis in dry cows. This product is effective against udder infections caused by the following susceptible microorganism: Streptococcus agalactiae.


Dosage



Administer at the time of drying-off by infusing each quarter, one time only, with a single 10mL syringe.


Administration



At the time of drying-off, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy disinfectant. Dry thoroughly. The hands of the operator should be washed and dried before administration of each treatment. Using the alcohol pads that are provided with each syringe wipe off teat, using a separate pad for each teat.

When using this product, remove plastic cover from tip of syringe and, while holding teat firmly, insert tip into streak canal, then push plunger and inject entire contents. After injection, grasp the end of the teat firmly, then gently massage the medication up the teat canal into the udder. It is recommended to use a suitable teat dip on all teats following treatment.


Warning



Discard all milk for 72 hours (6 milkings) following calving or later as indicated by the marketable quality of the milk.

Animals intended for human consumption must not be slaughtered within 14 days of the last treatment with go-dry™.

Use of this product in a manner other than as directed in the labeling might result in violative residues.

THIS PRODUCT WAS MANUFACTURED BY A NON-STERILIZING PROCESS.

RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED


Precautions



For use in dry cows only.

Discard empty container. Do not reuse.

Not for human use.

Keep this and all medications out of the reach of children.

Shake well before using.

It is a violation of Federal law to use go-dry™ in food-producing animals other than as directed in the labeling.


User Safety Warnings



Penicillins can cause allergic reactions in sensitized individuals. Topical exposure to penicillin may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing.

Persons with known hypersensitivity to penicillin should avoid exposure to this product.

In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.

The material safety data sheet contains more detailed occupational safety information.

To report side effects in users, to obtain more information or to obtain a Material Safety Data Sheet, call 1-866-562-4708.

STORE AT CONTROLLED ROOM TEMPERATURE: 20˚ - 25˚C (68˚-77˚F).

Manufactured for:
US VET Inc.
Hamilton, NY 13346

Approved by FDA under NADA # 065-081

INS12DC879 12               Rev. 03/2023


Package/Label Principal Display Panel



NDC 86108-012-10

go-dryTM

Penicillin G Procaine in Sesame Oil

100,000 units/10mL Syringe
For Intramammary Infusion in Dry Cows Only
Antibacterial


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