GENTACALM

Dechra Veterinary Products
American Pharmaceuticals and Cosmetics, Inc.

GENTACALM Topical Spray

FULL PRESCRIBING INFORMATION: CONTENTS*

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FULL PRESCRIBING INFORMATION

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GENTACALM
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

NDC 17033-335-12

Net Contents: 60 mL, 120 mL, or 240 mL Bottles

PRODUCT INFORMATION
ANADA 200-388, Approved by FDA
GENTAMICIN SULFATE WITH BETAMETHASONE
VALERATE TOPICAL SPRAY
(Gentamicin Sulfate, USP With Betamethasone
Valerate, USP Topical Spray)

         Veterinary
For Topical Use in Dogs Only
For Animal Use Only

CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics derived from the
fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate
salts of the antibiotics produced in this fermentation. The salts are weakly acidic
and freely soluble in water.

Gentamicin sulfate contains not less than 500 micrograms of gentamicin base per
milligram.

Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highly
effective topical treatment for bacterial infection of the skin In vitro,
gentamicin is bactericidal against a wide variety of gram-positive and gram-
negative bacteria isolated from domestic animals. ^1,2 Specifically, gentamicin is
active against the following organisms isolated from canine skin: Alcaligenes
sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive
and -negative Proteus sp., Escherichia coli, Enterobacter sp.,  Staphlyococcus sp.
and Streptococcus sp.

Betamethasone valerate emerged from intensive research as the most
promising of some 50 newly synthesized corticosteroids in the
experimental model described by McKenzie,³ et al. This human bioassay
technique has been found reliable for evaluating vasoconstrictor
properties of new topical corticosteroids and is useful in predicting clinical
efficacy.

Betamethasone valerate in veterinary medicine has been shown to provide
anti-inflammatory and antipruritic activity in the topical management of
corticosteroid-responsive infected superficial lesions in dogs.

Uses

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.

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.

Gentacalm 60 mL Bottle Label

60 mL Bottle Label

60 mL box image

120 mL bottle label image

120 mL box image

240 mL bottle image label

240 mL box image

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