SILVET L- lidocaine hydrochloride spray

SilVet L by

Drug Labeling and Warnings

SilVet L by is a Animal medication manufactured, distributed, or labeled by Henry Schein, Vetbiotek, Custom Veterinary Services, Inc., Swati Spentose Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

PRODUCT DESCRIPTION: SilVet L Anesthetic Spray soothes and helps to provide temporary relief of pain and itching caused by allergic conditions. Lidocaine is a local anesthetic and MicroSilver BG™ provides Antiseptic and Antibiofilm activity. Ceramide III helps support a healthy skin barrier. Pemulen and Glycofilm provide an immediate soothing effect and a protective surface matrix.

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Lidocaine Hydrochloride 2.4%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Purified Water, Glycerin, Propylene Glycol, Polysorbate 80, Cellulose Gum, Polysaccharide Gum-4 (Glycofilm), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Pemulen), Sodium Benzoate, Methylchloroisothiazolinone, Methylisothiazolinone, MicroSilver BG, N-Octadecanoylphytosphingosine (Ceramide III), and Disodium EDTA

SPL UNCLASSIFIED SECTION

SPECIES: Dogs and Horses

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE:Shake well before use. Spray 2 or 3 pumps on affected areas as required.

WARNINGS AND PRECAUTIONS

WARNING: KEEP OUT OF REACH OF CHILDREN. Wash hands after using.

PRECAUTIONS: Do not use on cats. For topical use on dogs and horses only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water and contact a veterinarian. If irritation persists or increases, discontinue use and consult a veterinarian.  Do not apply to entire body or to large areas of broken skn. Wash hands after use.

STORAGE AND HANDLING

STORAGE: Store at room temperature. Protect from freezing.

AVAILABLE THROUGH LICENSED VETERINARIANS ONLY.

QUESTIONS? (855) 724-3461

REORDER #: 057496

AH-057496-01 Rev: 12/14/2016

MicroSilver BG is a trademark of Bio-Gate AG

2 FL OZ. (59 mL) Package Principal Display Panel

HENRY SCHEIN®

ANIMAL HEALTH

NDC: 11695-1457-1

SilVet L ANESTHETIC SPRAY

LIDOCAINE HYDROCHLORIDE 2.4%
--------------------------
SOOTHING SPRAY FOR
RELIEF OF HOT SPOTS
--------------------------
NET CONTENTS: 2 FL OZ. (59 mL)

Distributed by:

Henry Schein Animal Health

Dublin, OH 43017

www.henryhscheinvet.com

HENRY SCHEIN

SEAL OF EXCELLENCE®

MicroSilver BG™

Ceramide III

PRODUCT DESCRIPTION: SilVet L Anesthetic Spray soothes and heops to provide temporary relief of pain and itching caused by allergic conditions. Lidocaine is a local anesthetic and MicroSilver BG™ provides Antiseptic and Antibiofilm activity. Ceramide III helps support a healthy skin barrier. Pemulen and Glycofilm provide an immediate soothing effect and a protective surface matrix.

ACTIVE INGREDIENT: Lidocaine Hydrochloride 2.4%

INACTIVE INGREDIENTS: Purified Water, Glycerin, Propylene Glycol, Polysorbate 80, Cellulose Gum, Polysaccharide Gum-4 (Glycofilm), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Pemulen), Sodium Benzoate, Methylchloroisothiazolinone and Methylisothiazolinone, MicroSilver BG, N- Octadecanoylphytosphingosine (Ceramide III), and Disodium EDTA

SPECIES: Dogs and Horses

DIRECTIONS FOR USE: Shake well before use. Spray 2 or 3 pumps on affected areas as required.

WARNING: KEEP OUT OF REACH OF CHILDREN. Wash hands after using.

PRECAUTIONS: Do not use on cats. For topical use on dogs and horses only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water and contact a veterinarian. If irritation persists or increases, discontinue use and consult a veterinarian. Do not apply to entire body or to large areas of broken skn. Wash hands after use.

STORAGE: Store at room temperature. Protect from freezing.

AVAILABLE THROUGH LICENSED VETERINARIANS ONLY.

QUESTIONS? (855) 724-3461

REORDER #: 057496

AH-057496-01 Rev: 12/14/2016

MicroSilver BG is a trademark of Bio-Gate AG

INGREDIENTS AND APPEARANCE

SILVET L 
lidocaine hydrochloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-1457
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1.416 mg  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CERAMIDE 3 (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-1457-1	1 in 1 BOX
1		59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/30/2017

Labeler - Henry Schein (603750329)

Registrant - Vetbiotek (079730642)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Veterinary Services, Inc.		619511483	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Swati Spentose Private Limited		650621472	api manufacture