BAYTRIL OTIC: Product Information (Page 2 of 2)

STORAGE:

Store between 4° and 25°C (40 — 77°F). Store in an upright position. Do not store in direct sunlight.

HOW SUPPLIED:

Baytril Otic (enrofloxacin/silver sulfadiazine)

Size Presentation
15 mL Oval plastic bottle with dropper tip and extended tip closure

REFERENCES:

  1. Hooper DC and Wolfson JS. Mechanisms of quinolone action and bacterial killing in quinolone antimicrobial agents. Washington DC, American Society for Microbiology, 2nd ed., 1993: 53-75.
  2. Gootz TD and Brightly KE. Fluoroquinolone antibacterial: mechanism of action, resistance and clinical aspects. Medicinal Research Reviews 1996:16 (5): 433-486.
  3. Drlica K and Zhoa X. DNA gyrase, topoisomerase IV and the 4-quinolones. Microbiology and Molecular Biology Reviews 1997: 61(3): 377-392.
  4. Fox CL. Silver sulfadiazine: a new topical therapy for Pseudomonas in burns. Archives of Surgery 1968: 96:184-188.
  5. Wlodkowski TJ and Rosenkranz HS. Antifungal activity of silver sulfadiazine. Lancet 1973: 2:739-740.
  6. Schmidt A. In vitro activity of climbazole, clotrimazole and silver sulfadiazine against isolates of Malassezia pachy-dermatis. J of Vet Medicine Series B 1997: 44:193-197.

Baytril Otic is sold by Elanco or its affiliates and is not a product of Bayer. The product name Baytril Otic is owned by Bayer and used under license.

Elanco US Inc
Shawnee, KS 66216 U.S.A.

© 2021 Elanco or its affiliates.

Approved by FDA under NADA # 141-176

April, 2021

90198885 LV2104

Elanco

Principal Display Panel — 15 mL Carton Label

Baytril™ Otic

(enrofloxacin/silver sulfadiazine)

Antibacterial-Antimycotic Emulsion

For Ototopical Use in Dogs

15 mL

12 bottles of 15 mL each

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

Federal law prohibits the extralabel use of this drug in food-producing animals.

Figure
(click image for full-size original)

Principal Display Panel — 15 mL Bottle Label

Baytril™ Otic

(enrofloxacin/silver sulfadiazine)

Antibacterial-Antimycotic Emulsion

For Ototopical Use in Dogs

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

Federal law prohibits the extralabel
use of this drug in food-producing
animals.

15 mL

Elanco US Inc Shawnee, KS 66216 U.S.A.

Approved by FDA under NADA # 141-176

90198884 LV2104

B2F1

Figure
(click image for full-size original)
BAYTRIL OTIC
enrofloxacin, silver sulfadiazine emulsion
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0076
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENROFLOXACIN (ENROFLOXACIN) ENROFLOXACIN 5 mg in 1 mL
SILVER SULFADIAZINE (SULFADIAZINE) SILVER SULFADIAZINE 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0076-2 12 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER (58198-0076-1)
1 NDC:58198-0076-1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (58198-0076-2)
2 NDC:58198-0076-3 6 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER (58198-0076-1)
2 NDC:58198-0076-1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (58198-0076-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141176 09/29/2000
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Elanco US Inc. 117617385 MANUFACTURE, ANALYSIS, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Bayer AG 323208116 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Lek Pharmaceuticals d.d. 364704288 API MANUFACTURE

Revised: 06/2021 Elanco US Inc.

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