Label: EQUINE WITH EPIITALIS FOR JOINT AND CARTILAGE MATRIX SUPPORT- - granule

  • NDC Code(s): 76208-004-49, 76208-004-52, 76208-004-58
  • Packager: American Aquatic Testing, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 10, 2011

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  • SPL UNCLASSIFIED SECTION

    Front Panel

    NDC 76208-004-52

    4CYTE
    EQUINEwith
    Epiitalis for Joint
    and Cartilage Matrix
    Support

    Starter Pack

    Granules
    Net Contents
    50g (1.76 oz)

    Lot #:
    Best used by:

    Manufactured By:
    Interpath Pty Ltd (Australia)

    Distributed By:
    American Aquatic Testing, Inc.
    Allentown, PA 18109

    Questions: (610) 434-9015
  • Active Ingredients

    Active Ingredients: per teaspoon
    A proprietary blend of Green Lipped
    Mussel (Perna Canaliculus),Abalone
    (Haliotis iris), Marine Cartilage…………………3.21g
    Epiitalis (plant extract) ……………………………0. 26g

  • INACTIVE INGREDIENT

        Inactive ingredients – Honey, Molasses powder
        nature identical Raspberry /vanilla Flavor, Sodium
        Caseinate, Tartaric Acid and Vitamin E.

  • VETERINARY INDICATIONS

    Indications:
    Recommended for horses to help support joint
    flexibility and mobility.
    May help ease occasional aches as a result of
    vigorous activity such as eventing or performance racing.

  • DOSAGE FORMS & STRENGTHS

    Directions for Use:
    For oral use in horses only
    Introduction dose: Start on 1 teaspoon daily for 3
    days and slowly increase to recommended loading dose.
     
    Loading dose:  Four (4) heaped teaspoons per day
    for first 4-6 weeks
    .
    Daily Maintenance Dose: Two (2) heaped teaspoons

    To make more palatable, granules may be crushed
    and blended with a binder such as molasses.

  • GENERAL PRECAUTIONS

    Caution:

    Safe use in pregnant animals or animals intended for
    breeding has not been proven.

     
    Do not use in animals with known allergies to shellfish.

    If lameness worsens, discontinue use and contact your
    veterinarian.


    An examination from a veterinarian is recommended prior
    to using this product.

  • WARNINGS

      Warnings:
     
    Keep out of the reach of children and animals.
    In case of accidental overdose, contact a health professional
    immediately.
    This product should not be given to animals intended
    for human consumption.
  • STORAGE AND HANDLING

    Storage: Store below 770F/250C, re-seal tightly after use

  • PRINCIPAL DISPLAY PANEL

    4CYTE Equine 50g Sachet

    4CYTE Equine 50g Sachet

  • PRINCIPAL DISPLAY PANEL

    4CYTE Equine 700g Sachet

    4CYTE Equine 700g Sachet

  • PRINCIPAL DISPLAY PANEL

    4CYTE Equine 700g Pail

    4CYTE Equine 700g Pail

  • INGREDIENTS AND APPEARANCE
    EQUINE WITH EPIITALIS FOR JOINT AND CARTILAGE MATRIX SUPPORT 
    - granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:76208-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEW ZEALAND GREEN MUSSEL (UNII: 1L5332YQ7U) (NEW ZEALAND GREEN MUSSEL - UNII:1L5332YQ7U) NEW ZEALAND GREEN MUSSEL366 mg  in 1 g
    BLACKFOOT ABALONE (UNII: 1KU16741MK) (BLACKFOOT ABALONE - UNII:1KU16741MK) BLACKFOOT ABALONE122 mg  in 1 g
    SHARK (UNII: KEK41AP35U) (SHARK - UNII:KEK41AP35U) SHARK122 mg  in 1 g
    PLATYCLADUS ORIENTALIS SEED (UNII: QDB7SF78HO) (PLATYCLADUS ORIENTALIS SEED - UNII:QDB7SF78HO) PLATYCLADUS ORIENTALIS SEED50 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76208-004-5250 g in 1 POUCH
    2NDC:76208-004-58700 g in 1 POUCH
    3NDC:76208-004-49700 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/10/2011
    Labeler - American Aquatic Testing, Inc. (847862299)
    Registrant - Interpath Pty. Ltd. (744466777)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrizeal Limited590627915manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Cawthron Institute590501698analysis
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