Claro: Product Information (Page 2 of 2)

MICROBIOLOGY:

The compatibility and additive effect of each of the components in CLARO® solution was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa in dogs enrolled in the clinical effectiveness study determined that florfenicol and terbinafine hydrochloride inhibit the growth of bacteria and yeast commonly associated with otitis externa in dogs. No consistent synergistic or antagonistic effect of the two antimicrobials was demonstrated. The addition of mometasone furoate to the combination did not impair antimicrobial activity to any clinically significant extent. In a field study (see EFFECTIVENESS), at least 10 isolates from successfully treated cases were obtained for S. pseudintermedius and M. pachydermatis.

EFFECTIVENESS:

In a well-controlled, double-masked field study, CLARO® was evaluated against a vehicle control in 221 dogs with otitis externa. One hundred and forty six dogs were treated with CLARO® and 75 dogs were treated with the vehicle control. All dogs were evaluated for safety. Treatment (1 mL) was administered once on Day 0 to the affected ear(s). Prior to treatment, the ear(s) was cleaned with saline. The dogs were evaluated on Days 0, 7, 14, and 30. Blood work and urinalysis were obtained on Day 0 pre-treatment and Day 30 at study completion. Four clinical signs associated with otitis externa were evaluated: erythema, exudate, swelling, and ulceration. Success was based on clinical improvement at Day 30. Of the 183 dogs included in the effectiveness evaluation, 72.5% of dogs administered CLARO® solution were successfully treated, compared to 11.1% of the dogs in the vehicle-control group (p = 0.0001).

ANIMAL SAFETY:

In a target animal safety study, CLARO® was administered aurally to 12-week-old Beagle puppies (4 dogs/sex/group) at 0X, 1X, 3X, and 5X the recommended dose once every 2 weeks for a total dosing period of 28 days (3 times the treatment duration). No clinically relevant treatment-related findings were noted in hearing tests, body weight, weight gain, or food consumption. CLARO® administration was associated with post-treatment ear wetness or clear aural exudate, increased absolute neutrophil count, decreased absolute lymphocyte and eosinophil counts, suppression of the adrenal cortical response to ACTH-stimulation, decreased adrenal weight and atrophy of the adrenal cortex, increased liver weight with hepatocellular enlargement/cytoplasmic change, and decreased thymus weight. Other potentially treatment-related effects included mild changes to AST, total protein, inorganic phosphorus, creatinine, and calcium.

STORAGE INFORMATION:

Store between 20°C – 25°C (68°F – 77°F), excursions are permitted 15°C – 30°C (59°F – 86°F).

HOW SUPPLIED:

CLARO® solution is supplied in a single-use dropperette in a blister.

Each dropperette contains one 1 mL dose.

CLARO® is available in cartons of two, ten, or twenty dropperettes.

Manufactured for
Elanco US Inc
Shawnee, KS 66216
Made in Germany
CLARO, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
©2020 Elanco or its affiliates.

Approved by FDA under NADA # 141-440

October, 2020
87227014, LV2010

Elanco

Principal Display Panel — 1 mL Carton Label

CLARO®
(florfenicol, terbinafine,
mometasone furoate)

Otic Solution for use in dogs only

Do Not Use in Cats.

CAUTION: Federal (U.S.A.) law restricts this
drug to use by or on the order of a licensed
veterinarian.

Approved by FDA under NADA # 141-440

Net Contents: 2 x 1 mL
single dose dropperettes

See package insert for complete safety and
administration information prior to use.

Elanco

Principal Display Panel -- 1 mL Carton Label
(click image for full-size original)
CLARO
florfenicol, terbinafine, mometasone furoate solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0027
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLORFENICOL (FLORFENICOL) FLORFENICOL 16.6 mg in 1 mL
TERBINAFINE (TERBINAFINE) TERBINAFINE 14.8 mg in 1 mL
MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 2.2 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0027-2 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TUBE, WITH APPLICATOR in 1 BLISTER PACK This package is contained within the CARTON (58198-0027-2) and contains a TUBE, WITH APPLICATOR (58198-0027-1)
1 NDC:58198-0027-1 1 mL in 1 TUBE, WITH APPLICATOR This package is contained within a BLISTER PACK and a CARTON (58198-0027-2)
2 NDC:58198-0027-3 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TUBE, WITH APPLICATOR in 1 BLISTER PACK This package is contained within the CARTON (58198-0027-3) and contains a TUBE, WITH APPLICATOR (58198-0027-1)
2 NDC:58198-0027-1 1 mL in 1 TUBE, WITH APPLICATOR This package is contained within a BLISTER PACK and a CARTON (58198-0027-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141440 11/15/2015
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
KVP Pharma Veterin Produkte GmbH 320324445 ANALYSIS, LABEL, MANUFACTURE, PACK
Establishment
Name Address ID/FEI Operations
Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd. 421271589 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Symbiotec Pharmalab Private Limited 650328805 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917647 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Gedeon Richter Plc. 644781932 API MANUFACTURE

Revised: 05/2021 Elanco US Inc.

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