Surolan: Product Information (Page 2 of 2)

REFERENCES

  1. Pietschmann S. et al. (2009) Synergistic effects of miconazole and polymyxin B on microbial pathogens. Veterinary Research Communications 33(6), 489-505
  2. Bolinder A. et al. (2006) In vivo efficacy study of the anti-inflammatory properties of Surolan The Canadian Journal of Veterinary Research 70, 234-236

Principal Display Panel — 15 mL Carton Label

NDC 0986-0813-15

15 mL

CA0813

Surolan™

otic suspension
(miconazole nitrate,
polymyxin B sulfate,
prednisolone acetate)

For otic use in dogs only.

CAUTION:

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

NADA 141-298

Approved by FDA

Elanco

Principal Display Panel -- 15 mL Carton Label
(click image for full-size original)

Principal Display Panel — 15 mL Bottle Label

NDC 0986-0813-15

Surolan

otic suspension
(miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

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

15 mL

Elanco

Principal Display Panel -- 15 mL Bottle Label
(click image for full-size original)

Principal Display Panel — 30 mL Carton Label

NDC 0986-0813-30

30 mL

Surolan

otic suspension
(miconazole nitrate,
polymyxin B sulfate,
prednisolone acetate)

For otic use in dogs only.

CAUTION:

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

Approved by
FDA under
NADA# 141-298

Elanco

Principal Display Panel -- 30 mL Carton Label
(click image for full-size original)

Principal Display Panel — 30 mL Bottle Label

NDC 0986-0813-30

Surolan

otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

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

30 mL

Elanco

Principal Display Panel -- 30 mL Bottle Label
(click image for full-size original)
SUROLAN
miconazole nitrate, polymyxin b sulfate, prednisolone acetate solution/ drops
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0986-0813
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 23 mg in 1 mL
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B .05293 mg in 1 mL
PREDNISOLONE ACETATE (PREDNISOLONE) PREDNISOLONE ACETATE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0986-0813-15 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
1 15 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (0986-0813-15)
2 NDC:0986-0813-30 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
2 30 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (0986-0813-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141298 12/30/2009
Labeler — Elanco Animal Health Co (807447169)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 370005019 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A., 450630343 MANUFACTURE, PACK, LABEL

Revised: 11/2019 Elanco Animal Health Co

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