BIOCALM- lidocaine hydrochloride spray

BioCalm by

Drug Labeling and Warnings

BioCalm by is a Animal medication manufactured, distributed, or labeled by VetBiotek, Inc., Mahendra Chemicals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, N-Octadecanoylphytosphingosine (Ceramide III) and Disodium EDTA

INDICATIONS & USAGE

BioCalm Spray: A soothing and calming spray with Lidocaine, MicroSilver BG and Ceramide III for enhanced antiseptic activity and to help provide temporary relief of hot spots and non-specific skin irratations in dogs and horses.

PRODUCT DESCRIPTION: BioCalm Spray soothes and helps to provide temporary relief of pain and itching caused by allergic conditions. Lidocaine is a local anesthetic. Ceramide III helps support health skin. Pemulen and Glycofilm provide an immediate soothing effect and a protective surface matrix.

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

SPECIES: Dogs and Horses

GENERAL PRECAUTIONS

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

STORAGE AND HANDLING

STORAGE: Store at room temperature. Protect from freezing.

SPL UNCLASSIFIED SECTION

AVAILABLE THROUGH LICENSED VETERINARIANS ONLY

MANUFACTURED FOR: VetBiotek Inc., Largo, Florida USA 888-798-2030
www.vetbiotek.com

VBDBC0002 Rev: 01212016 CVS

MicroSilver BG is a trademark of Bio-Gate AG

PRINCIPAL DISPLAY PANEL

BioCalm Spray

Lidocaine Hydrochloride 2.4%

Soothing Spray for Relief of Hot Spots

SHAKE WELL BEFORE USE

2 oz. (59 mL)

MicroSilver BG   Ceramide III

VetBiotek Innovative Solutions

INGREDIENTS AND APPEARANCE

BIOCALM 
lidocaine hydrochloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86056-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	24 mg  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86056-029-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2016

Labeler - VetBiotek, Inc. (079730642)

Establishment
Name	Address	ID/FEI	Business Operations
Mahendra Chemicals		650481992	api manufacture