BIOCALM MOUSSE- pramoxine hydrochloride shampoo

BioCalm by

Drug Labeling and Warnings

BioCalm by is a Animal medication manufactured, distributed, or labeled by VetBiotek, Inc., Custom Veterinary Services, Inc., NetQem, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Pramoxine Hydrochloride 1%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Purified Water, Cocamidopropyl Betaine, Glycerin, Polysorbate 80, Acrylates Copolymer, Polyquaternium 7, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, N-Octadecanoylphytosphingosine (Ceramide III) and MicroSilver.

INDICATIONS & USAGE

BioCalm Mousse: Combines a proprietary formulation of Pramoxine and MicroSilver BG™ for enhanced antiseptic activity and to help provide temporary relief from itching. Ceramide III helps support healthy skin.

PRODUCT DESCRIPTION: BioCalm Mousse contains Pramoxine, a mild local anesthetic agent indicated for the relief of skin irritation. BioCalm Mousse also contains mild cleansing bases for the gentle cleansing of the skin. Formulated for the adjunctive topical management to help provide temporary relief from itching.

SPECIES: Dogs, Cats and Horses

DIRECTIONS: Shake well before use. Brush the hair coat before application. For dogs and cats, dispense the volume of product onto the dry hair coat, based on weight, as indicated in the table below. Thoroughly, but gently, massage into the dry hair coat to allow the product to reach the skin. Repeat as necessary to cover the whole body of the animal. For horses, use focally on areas where application is warranted. Do not rinse off and allow to dry.

Use as often as necessary. Safe to use with topical flea products and other topical skin medications.

For dogs and cats:
Under 11 lbs . . . 1 pump per 2 lbs
12-88 lbs . . . 1 pump per 4 lbs
Over 89 lbs . . . 1 pump per 6 lbs
Dosage may be doubled for long-haired dogs

For horses: Use focally to cover the area of application.

GENERAL PRECAUTIONS

PRECAUTIONS: For topical use only on dogs, cats and horses. Avoid contact with eyes and mouth. If eye contact occurs, rinse thoroughly with water, discontinue use and immediately consult a veterinarian.

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

VBDBC0200 Rev: 01212016 CVS

MicroSilver BG is a trademark of Bio-Gate AG

PRINCIPAL DISPLAY PANEL

BioCalm Mousse

Pramoxine Hydrochloride 1%

Soothing and Calming Mousse for Relief of Itching

SHAKE WELL BEFORE USE

6.8 oz. (200 mL)

Mixrosilver BG Logo     Ceramide III Logo

VetBiotek Innovative Solutions

INGREDIENTS AND APPEARANCE

BIOCALM  MOUSSE
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86056-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CERAMIDE 3 (UNII: 4370DF050B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
SILVER (UNII: 3M4G523W1G)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86056-028-07	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/10/2016

Labeler - VetBiotek, Inc. (079730642)

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

Establishment
Name	Address	ID/FEI	Business Operations
NetQem, LLC		362973500	api manufacture