HEXADERM MAX- chlorhexidine gluconate shampoo

HexaDerm by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Chlorhexidine gluconate 4%

INACTIVE INGREDIENT

OTHER INGREDIENTS: Purified Water, Cocamidopropyl Betaine, Nonoxynol 12, PEG-5 Cocamide, PEG 150 Distearate, Lauramine Oxide, Ethyl Glycol Distearate, Phenoxyethanol, synthetic fluorphlogopite/tin oxide/titanium dioxide (Syncrystal Soft Silver), Xanthan Gum, Fragrance,          N-Octadecanoylphytosphingosine (Ceramide Ill) and MicroSilver

INDICATIONS & USAGE

PRODUCT DESCRIPTION:HexaDerm Max Shampoo combines a proprietary formulation of Chlorhexidine and MicroSilver BG for enhanced antiseptic and antibiofilm activity. Ceramide III helps support healthy skin.

DIRECTIONS FOR USE: Shake well before use. Wet the hair coat with warm water and apply small quantities of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet's body to ensure good contact with the skin. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for four weeks, then reduce to once a week, or as directed by your veterinarian. Do not allow the animal to lick while bathing to prevent ingestion.

GENERAL PRECAUTIONS

SPECIES: Dogs, Cats and Horses

WARNING: Keep out of reach of children. Wash hands after using.

PRECAUTIONS: For topical use on dogs, cats and horses. Avoid contact with eyes and mucous membranes. If contact occurs or skin irritation develops, 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

VBDHD0008  / VBDHD0016 REV / VBDHD0128 Rev: 12072018-C / REV: 12072018-C / REV: 12072018-C

MicroSilver BG is a trademark of Bio-Gate AG.

PRINCIPAL DISPLAY PANEL

HexaDerm Max

Shampoo

Chlorhexidine  Gluconate 4%

Deep Cleansing and Deodorizing

Soap-Free Antiseptic Shampoo

SHAKE WELL BEFORE USE

8 oz. (237 ml) 16 oz. (473 mL) 1 GALLON (3.78L)

MicroSilver BG Logo     Ceramide III Logo

VetBiotek

Innovative Solutions

INGREDIENTS AND APPEARANCE

HEXADERM  MAX
chlorhexidine gluconate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86056-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86056-012-08	236 mL in 1 BOTTLE, PLASTIC
2	NDC: 86056-012-16	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 86056-012-28	3785.4 mL in 1 PACKAGE

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
SYN-TECH CHEM. & PHARM. CO., LTD		656002532	api manufacture