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

Equine with Epiitalis for Joint and Cartilage Matrix Support by

Drug Labeling and Warnings

Equine with Epiitalis for Joint and Cartilage Matrix Support by is a Animal medication manufactured, distributed, or labeled by American Aquatic Testing, Inc., Interpath Pty. Ltd., Nutrizeal Limited, Cawthron Institute. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

4CYTE Equine 700g Sachet

PRINCIPAL DISPLAY PANEL

4CYTE Equine 700g Pail

INGREDIENTS AND APPEARANCE

EQUINE WITH EPIITALIS FOR JOINT AND CARTILAGE MATRIX SUPPORT 
- granule

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 76208-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEW ZEALAND GREEN MUSSEL (UNII: 1L5332YQ7U) (NEW ZEALAND GREEN MUSSEL - UNII:1L5332YQ7U)	NEW ZEALAND GREEN MUSSEL	366 mg  in 1 g
BLACKFOOT ABALONE (UNII: 1KU16741MK) (BLACKFOOT ABALONE - UNII:1KU16741MK)	BLACKFOOT ABALONE	122 mg  in 1 g
SHARK (UNII: KEK41AP35U) (SHARK - UNII:KEK41AP35U)	SHARK	122 mg  in 1 g
PLATYCLADUS ORIENTALIS SEED (UNII: QDB7SF78HO) (PLATYCLADUS ORIENTALIS SEED - UNII:QDB7SF78HO)	PLATYCLADUS ORIENTALIS SEED	50 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76208-004-52	50 g in 1 POUCH
2	NDC: 76208-004-58	700 g in 1 POUCH
3	NDC: 76208-004-49	700 g in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/10/2011

Labeler - American Aquatic Testing, Inc. (847862299)

Registrant - Interpath Pty. Ltd. (744466777)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrizeal Limited		590627915	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cawthron Institute		590501698	analysis