Label: ALBADRY PLUS- novobiocin sodium and penicillin g procaine injection, solution

  • NDC Code(s): 54771-3139-1, 54771-3139-2, 54771-3139-9
  • Packager: Zoetis Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 26, 2020

If you are a consumer or patient please visit this version.

  • VETERINARY INDICATIONS

    For the Treatment of Subclinical Mastitis in Dry Cows

    For Udder Instillation in Dry Cows Only

    FOR USE IN ANIMALS ONLY—NOT FOR HUMAN USE

    Restricted Drug—Use Only as Directed (California)

  • DESCRIPTION

    Each 10 mL PLASTET® Disposable Syringe contains:
     Novobiocin sodium equiv. to novobiocin 400 mg
     Penicillin G procaine 200,000 IU
     Chlorobutanol anhydrous
    (chloral derivative—used as a preservative)
    in a special bland vehicle
     50 mg

    Manufactured by a non-sterilizing process.

  • INDICATIONS FOR USE

    ALBADRY PLUS Suspension is indicated for the treatment, in dry cows only, of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

  • WARNINGS

    • Do not use less than 30 days prior to calving.
    • Milk from treated cows must not be used for food during the first 72 hours after calving.
    • Treated animals must not be slaughtered for food for 30 days following udder infusion.
  • PRECAUTION

    Administration of this product in any manner other than shown under DOSAGE may result in drug residues.

  • DOSAGE

    Infuse one tube per quarter at start of dry period (but not less than 30 days prior to calving).

    Shake Well Before Using

  • DIRECTIONS FOR USING THE FLEXI-TUBE® SYSTEM

    The FLEXI-TUBE is designed to provide the choice of either insertion of the full cannula, as has traditionally been practiced, or insertion of no more than ⅛ inch of the cannula, as recommended by the National Mastitis Council.

    • Full Insertion: Remove the blue end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product.
      • Figure a.
    • Partial Insertion: Remove both the blue end cap and the red cannula by pushing sideways as shown. Gently insert the exposed blue tip into the teat canal; carefully infuse the product.
      • Figure b.
  • ADMINISTRATION

    At the time of drying off, but not less than 30 days prior to calving, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy antiseptic. Dry the teats and udder thoroughly. Infuse each quarter using the following procedure. Using the alcohol pads provided, scrub each teat end clean using a separate pad for each teat. Warm ALBADRY PLUS Suspension to body temperature and shake thoroughly. Choose the desired insertion length (full or partial) and insert tip into teat canal. Instill entire contents into the quarter. Massage the udder after treatment to distribute the ALBADRY PLUS Suspension throughout the quarters. Using a suitable teat dip, dip all teats following treatment.

  • SPL UNCLASSIFIED SECTION

     Discard Empty Container; DO NOT REUSE
    KEEP OUT OF REACH OF CHILDREN
  • STORAGE CONDITIONS

    Store at controlled room temperature 20° to 25° C (68° to 77° F).

  • HOW SUPPLIED

    ALBADRY PLUS Suspension is available in unbroken packages of 12–10 mL PLASTET Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and unbroken packages of 144–10 mL PLASTET Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA #055-098

    Product of the United Kingdom  
    Zoetis Inc.
    Kalamazoo, MI 49007 USA
    By Norbrook Laboratories Limited
    Newry, BT35 6JP, Northern Ireland
    Revised: April 2020

    002544L09

  • PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label

    10 mL (.33 FI Oz) Suspension

    ALBADRY PLUS®
    Suspension

    penicillin G procaine and novobiocin sodium intramammary infusion

    DRY COW FORMULA

    PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label
  • PRINCIPAL DISPLAY PANEL - 12 x 10 mL Syringe Carton

    ALBADRY PLUS®
    Suspension

    PENICILLIN G PROCAINE AND NOVOBIOCIN SODIUM INTRAMAMMARY INFUSION

    DRY COW FORMULA

    Indicated for intramammary infusion in the treatment of subclinical mastitis caused by
    susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

    Contains: 400 mg novobiocin sodium plus 200,000 IU penicillin G procaine
    per 10 mL syringe

    Approved by FDA under NADA #055-098 
    12-10 mL (.33 FI Oz) PLASTET® Disposable Syringes / 12 ALCOHOL PADS INCLUDED

    zoetis

    Albadry Plus Suspension Carton
  • PRINCIPAL DISPLAY PANEL - 144 x 10 mL Syringe Pail Label

    TAKE TIME
    OBSERVE LABEL
    DIRECTIONS

    ALBADRY PLUS®
    Suspension

    PENICILLIN G PROCAINE AND NOVOBIOCIN SODIUM

    DRY COW FORMULA

    Indicated for intramammary infusion in the treatment of subclinical mastitis caused by
    susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

    Contains: 400 mg novobiocin sodium plus 200,000 IU penicillin G procaine
    per 10 mL syringe

    1404000
    002544L04

    Approved by FDA under NADA #055-098
    144-10 mL (.33 FI Oz) PLASTET® Disposable Syringes / 144 ALCOHOL PADS INCLUDED

    zoetis

    Albadry Plus Suspension Label
  • INGREDIENTS AND APPEARANCE
    ALBADRY PLUS 
    novobiocin sodium and penicillin g procaine injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3139
    Route of AdministrationINTRAMAMMARY
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NOVOBIOCIN SODIUM (UNII: Q9S9NQ5YIY) (NOVOBIOCIN - UNII:17EC19951N) NOVOBIOCIN400 mg  in 10 mL
    PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C) PENICILLIN G200000 [iU]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROBUTANOL (UNII: HM4YQM8WRC) 50 mg  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3139-112 in 1 CARTON
    1NDC:54771-3139-910 mL in 1 SYRINGE
    2NDC:54771-3139-2144 in 1 PAIL
    2NDC:54771-3139-910 mL in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA05509801/07/1983
    Labeler - Zoetis Inc. (828851555)