Label: U.S. VET MASTI-CLEAR- penicillin g procaine in sesame oil suspension
- NDC Code(s): 86108-014-10
- Packager: US Vet Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated August 24, 2021
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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:
- Inflammation of the udder or teat. Inflammation may be recognized by redness, swelling, elevated temperature, or pain in the affected part.
- Abnormal milk. Presence of flakes or clots in the milk, or milk of a watery character is usually indicative of a mastitis infection.
- 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.
- Discard all milk for 60 hours (5 milkings) after the latest treatment.
- Animals intended for human consumption must not be slaughtered within 3 days of the last treatment with Masti-Clear®.
- Use of this product in a manner other than as directed in the labeling might result in violative residues.
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.
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
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – syringe label
INGREDIENTS AND APPEARANCE
U.S. VET MASTI-CLEAR
penicillin g procaine in sesame oil suspension
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86108-014 Route of Administration INTRAMAMMARY Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C) PENICILLIN G 100000 [iU] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86108-014-10 12 in 1 BOX 1 100000 in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA065081 11/02/2020 Labeler - US Vet Inc (117160633) Establishment Name Address ID/FEI Business Operations GC Hanford Manufacturing Company 002238863 MANUFACTURE, ANALYSIS