GentaSoothe

Teva Animal Health, Inc.
American Pharmaceuticals and Cosmetics, Inc.

GentaSoothe Topical Spray

FULL PRESCRIBING INFORMATION: CONTENTS*

• Front Panel Label
• Chemistry, Pharmacology and Toxicity
• WARNING
• INDICATIONS AND GENTASOOTHE CONTRAINDICATIONS
• GENTASOOTHE DOSAGE AND ADMINISTRATION
• SIDE EFFECTS AND PRECAUTIONS
• HOW SUPPLIED AND STORAGE
• REFERENCES
• Bottle Label Image
• Front Onsert Image
• Back Onsert Image
• GS Dozen Box Image

FULL PRESCRIBING INFORMATION

Front Panel Label

GentaSoothe
Topical Spray

(Gentamicin Sulfate With
Betamethasone Valerate)

Veterinary

CAUTION: Federal Law restricts this drug
to use by or on the order of a
licensed veterinarian

ANADA 200-388, Approved by FDA

Net Contents: 120 mL

TEVA

Teva Animal Health, Inc.

Chemistry, Pharmacology and Toxicity

WARNING

INDICATIONS AND CONTRAINDICATIONS

INDICATIONS: For the treatment of infected superficial lesions in dogs
caused by bacteria susceptible to gentamicin.

CONTRAINDICATIONS: If hypersensitivity of any of the components
occurs, discontinue treatment and institute appropriate therapy.

GENTASOOTHE DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION: Prior to treatment, remove excessive
hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6
inches from the lesion and depress the sprayer head twice. Administer 2
to 4 times daily for 7 days.

Each depression of the sprayer head delivers 0.7 mL of Gentamicin
Sulfate With Betamethasone Valerate Topical Spray.

SIDE EFFECTS AND PRECAUTIONS

SIDE EFFECTS: Side effects such as SAP and SGPT enzyme
elevations, weight loss, anorexia, polydipsia and polyuria have occurred
following parenteral or systemic use of synthetic corticosteroids in dogs.
Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing's syndrome in dogs has been reported in association with
prolonged or repeated steroid therapy.

PRECAUTIONS: Antibiotic susceptibility of the pathogenic organism(s)
should be determined prior to use of this preparation. Use of topical
antibiotics may permit overgrowth of non-susceptible bacteria, fungi or
yeasts. If this occurs, treatment should be instituted with other
appropriate agents as indicated.

Administration of recommended dose beyond 7 days may result in
delayed wound healing. Animals treated longer than 7 days should be
monitored closely.

Avoid ingestion. Oral or parenteral use of corticosteroids, depending on
dose, duration and specific steroid may result in inhibition of endogenous
steroid production following drug withdrawal.

In patients presently receiving or recently withdrawn from systemic
corticosteroids treatments, therapy with a rapidly acting corticosteroid
should be considered in especially stressful situations.

If ingestion should occur, patients should be closely observed for the
usual signs of adrenocorticoid overdosage, which includes sodium
retention, potassium loss, fluid retention, weight gains, polydipsia and/or
polyuria. Prolonged use or overdosage may produce adverse
immunosuppressive effects.

HOW SUPPLIED AND STORAGE

HOW SUPPLIED: Plastic spray bottles containing 60 mL,
and 120 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

Store upright between 2⁰C and 30⁰C (36⁰F and 86⁰F).

REFERENCES

REFERENCES:

1. Hennessy, PW, et al. In vitro activity of gentamicin against bacteria
isolated from domestic animals.  Veterinary Medicine/Small Animal
Clinician. November 1971; 1118-1122.

2. Bachmann, HJ, et al. Comparative in vitro activity of gentamicin and
other antibiotics against bacteria isolated from clincial samples from
dogs, cats, horses and cattle. Veterinary Medicine/Small Animal
Clinician. October 1975; 1218-1222.

3. McKenzie, HW and Atkinson, RM. Topical activities of betamethasone
esters in Man. Arch Derm. May 1964;741-746.

Manufactured for                                                Iss1110
Teva Animal Health, Inc.
St. Joseph, MO 64503

Bottle Label Image

Bottle Label Image

Front Onsert Image

Front Onsert Image

Back Onsert Image

Back Onsert Image

GS Dozen Box Image

GS Dozen Box Image