Animal NDC 86108-014-10 U.s. Vet Masti-clear
Penicillin G Procaine In Sesame Oil
Animal Product Information
Field Name | Field Value |
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Animal NDC Code | 86108-014-10 |
Proprietary Name | U.s. Vet Masti-clear 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 | Otc Animal Drug |
Usage Information |
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Active Ingredient(s) |
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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. |
U.s. Vet Masti-clear 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 lactating cows. This product is effective against udder infection caused by the following susceptible microorganisms:
Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
For the best results, it should be used promptly at the first signs of mastitis.
Signs of mastitis include:
1. Inflammation of the udder or teat. Inflammation may be recognized by redness, swelling, elevated temperature, or pain in the affected part.2. Abnormal milk. Presence of flakes or clots in the milk, or milk of a watery character is usually indicative of a mastitis infection.3. High white-cell counts. The routine use of the California Mastitis Test is encouraged. A high incidence of scores in excess of CMT 2 or a high CMT score on bulk milk samples may indicate a potential mastitis problem. In these situations a veterinarian should be consulted for definitive diagnosis and recommendations.
Directions For Use
Dosage: The dose is 10mL of this product per infected quarter administered by intramammary infusion. Treatment may be repeated at intervals of 12 hours. Do not administer more than three consecutive doses.
Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy disinfectant. Dry thoroughly. The hands of the operator should be washed and dried before the administration of each treatment. Using the alcohol pads that are provided with each syringe wipe off teat, using a separate pad for each teat. Appropriate sanitation and management procedures to prevent and/or control bovine mastitis should be instituted.
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 milk cistern.
Treated quarters should not be milked for at least six hours after treatment but should be milked at regular intervals thereafter. Treatment may be repeated at 12 hour intervals, up to a total of three doses, as indicated by the clinical response.
NOTE: Mastitis cannot be considered cured until bacteriologic examination of milk samples taken approximately three weeks after treatment demonstrates the absence of causative microorganisms.
Warning
1. Discard all milk for 60 hours (5 milkings) after the latest treatment.2. Animals intended for human consumption must not be slaughtered within 3 days of the last treatment with Masti-Clear®.3. Use of this product in a manner other than as directed in the labeling might result in violative residues.
Precautions
Keep out of reach of children. Discard empty container; do not reuse. It is a violation of Federal law to use Masti-Clear® in food-producing animals other than as directed in the labeling. If abnormal milk, redness, or swelling persists or increases, discontinue use and consult your veterinarian.
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)
RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED
THIS PRODUCT WAS MANUFACTURED BY A NON-STERILIZING PROCESS.
Manufactured for:
US VET Inc.
Hamilton, NY 13346
Approved by FDA under NADA # 065-081
INS012LC 13 Rev. 02/2021
Package/Label Principal Display Panel – Carton Label
NDC 86108-014-10
MASTI-CLEAR®
Penicillin G Procaine in Sesame Oil
100,000 units/10mL Syringe
For Intramammary Infusion in Lactating Cows Only
Antibacterial
Single Dose Disposable Syringe
CONTENTS:
12-10 mL SYRINGES
12 Alcohol Pads
Package/Label Principal Display Panel – Syringe Label
NDC 86108-014-10
MASTI-CLEAR®
Penicillin G Procaine in Sesame Oil
100,000 units/10mL Syringe
For Intramammary Infusion in Lactating Cows Only
Antibacterial
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.