Osurnia: Product Information (Page 2 of 2)

Animal Safety:

In a target animal safety study, 24 mixed breed dogs (4 dogs/sex/ group) were aurally administered 0X, 1X (1 mL/ear or 2 mL/dog with repeated administration in 7 days) or 5X (5 mL/ear or 10 mL/dog with repeated administration in 7 days) doses of OSURNIA for a total of 6 administrations in 5 weeks. All dogs remained in good health with normal hearing throughout the study. Decreased weight gain was noted in the 1X and 5X groups compared to the control group. Clinical findings included post-administration ear wetness in 1X and 5X groups and unilateral, transient brown/red discharge from one ear each in two 5X dogs, with erythema in one dog after the 4th application. Local microscopic changes in ears (without clinical effects) included: slight or moderate unilateral vesicle formation within the epithelium of the tympanic membrane in two 1X and four 5X dogs, and unilateral mucosal ulceration in the lining of the middle ear cavity in three 5X dogs. Three 5X dogs had slightly elevated ALT activity, accompanied by minimal or mild microscopic hepatocellular vacuolation (in two dogs). Cortisol response to ACTH stimulation was decreased, but within the normal reference range, in 1X dogs. The 5X dogs had a decrease in serum cortisol levels after ACTH stimulation (below normal reference range) accompanied by decreased adrenal gland and thymic weights with minimal adrenal cortical atrophy and slight (in three dogs) or moderate (in one dog also noted with slightly lower lymphocyte counts) lymphoid depletion of the thymus. The ACTH stimulation test results are consistent with systemic absorption of betamethasone resulting in a likely reversible suppression of the hypothalamic-pituitary-adrenal axis as seen with administration of exogenous corticosteroids.

Storage Conditions:

OSURNIA should be stored under refrigerated conditions between 36° — 46° F (2° — 8° C). To facilitate comfort during administration, OSURNIA may be brought to room temperature and stored for up to three months.

How Supplied:

OSURNIA is a gel in a single use tube with a flexible soft tip, supplied in cartons containing 2 or 20 tubes.

NADA # 141-437, Approved by FDA

Elanco, OSURNIA and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

Manufactured for:
Elanco US Inc. Greenfield, IN 46140, USA
Product of Great Britain

10/16

Elanco™

Principal Display Panel — 2 Tube Carton

Osurnia™

(florfenicol ● terbinafine ● betamethasone acetate)

Otic gel for dogs

Elanco

Caution: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.

2 Tubes

Otic gel

NADA 141-437, Approved by FDA

Keep this and all drugs out of the reach of children.

Before using this drug, read package insert for complete product information.

Net contents: 2 tubes. Each 1 mL tube contains
10 mg florfenicol, 10 mg terbinafine and 1 mg
betamethasone acetate and the inactive ingredients
propylene carbonate, glycerol formal, hypromellose,
phospholipid, oleic acid and BHT.

Product #615044

Principal Display Panel -- 2 Tube Carton
(click image for full-size original)

Principal Display Panel — 1 mL Tube Label

Twist to open

EP100451AMX 926987

Osurnia™

(florfenicol ● terbinafine ● betamethasone acetate)

Otic gel for dogs

1 dose

Elanco

Principal Display Panel -- 1 mL Tube Label
(click image for full-size original)

Principal Display Panel — 20 Tube Carton Label

Osurnia™

(florfenicol ● terbinafine ● betamethasone acetate)

Otic gel for dogs

Elanco

Before using this drug, read package insert for complete product information.

Caution: Federal (USA) law
restricts this drug to use by or on
the order of a licensed veterinarian.

NADA 141-437,

Approved by FDA

20 Tubes

Otic gel

Principal Display Panel -- 20 Tube Carton Label
(click image for full-size original)

Principal Display Panel — 1 mL Tube Label

Twist to open

EP100451AMX 926987

Osurnia™

(florfenicol ● terbinafine ● betamethasone acetate)

Otic gel for dogs

1 dose

Elanco

Principal Display Panel -- 1 mL Tube Label
(click image for full-size original)
OSURNIA
florfenicol, terbinafine, betamethasone acetate gel
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-4710
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
florfenicol (florfenicol) florfenicol 10 mg in 1 mL
terbinafine (terbinafine) terbinafine 10 mg in 1 mL
betamethasone acetate (betamethasone) betamethasone acetate 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
OLEIC ACID
HYDROGENATED SOYBEAN LECITHIN
HYPROMELLOSE, UNSPECIFIED
PROPYLENE CARBONATE
GLYCEROL FORMAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-4710-1 2 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
1 1 mL in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (58198-4710-1)
2 NDC:58198-4710-3 20 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
2 1 mL in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (58198-4710-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141437 05/01/2015
Labeler — Elanco US Inc. (966985624)

Revised: 09/2020 Elanco US Inc.

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