NDC Code(s) : 54771-1001-1
Packager : Zoetis Inc.

Category : PRESCRIPTION ANIMAL DRUG LABEL

DEA Schedule : none

Marketing Status : New Animal Drug Application

INGREDIENTS AND APPEARANCE

Hylartin Vhyaluronate sodium INJECTION
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-1001
Route of Administration INTRA-ARTICULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hyaluronate sodium(UNII: YSE9PPT4TH)
(hyaluronic acid - UNII:S270N0TRQY) 		hyaluronate sodium10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride(UNII: 451W47IQ8X)8.5 mg in 1 mL
sodium phosphate, dibasic, dihydrate(UNII: 94255I6E2T)
sodium phosphate, monobasic(UNII: 3980JIH2SW)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54771-1001-11 in 1 CARTON
12 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA112048 11/15/1984 09/25/2018

LABELER - Zoetis Inc.(828851555)

PRINCIPAL DISPLAY PANEL

2ml

HYLARTIN ® V
sodium hyaluronate
injection 10 mg/mL

Caution
Federal law restricts this drug to
use by or on the order of a licensed
veterinarian

Sterile

Contents : One 2 mL syringe

Each mL contains: Sodium hyaluronate
10.0 mg, sodium chloride 8.5 mg,
disodium hydrogen phosphate
dihydrate 0.28 mg, sodium dihydrogen
phosphate hydrate 0.04 mg, water for
injection USP q.s.

Do not use in horses intended for human
consumption.

Dosage: 2 mL, carpal-fetlock/4 mL, hock

See package insert

Do not use if numerous small air
bubbles are present throughout the
solution

For intra-articular injection in horses
only.

Store at 2° to 8°C

Protect from freezing

Protect from light

NADA 112-048, Approved by FDA

Made in Sweden by:
AMO Uppsala AB, Rapsgatan 7
Box 6406, SE-751 36 Uppsala, Sweden

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

PRINCIPAL DISPLAY PANEL - 2ml Syringe Carton