Bionect by Innocutis Holdings LLC BIONECT-

Bionect by

Drug Labeling and Warnings

Bionect by is a Other medication manufactured, distributed, or labeled by Innocutis Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Bionect Cream is a white Viscous cream. The principal componet is the sodium salt of hyaluronic acid (0.02%). Hyaluronic acid is a biological polysaccharide (glycisaminiglycan) and is a major componet of the estracellular matrix of the connective tissues.

Indications

Bionect is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post operatice incisions, irritations of the skin, and first and second degree burns, The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction and desiccation.

Directions

The wounds or ulcers should be cleaned and disinfected prior to treatment. In the event of the long-standing ulcers, it may be advisable to clean and/or to debride the wound by surgical or enzymatic means, prior to treatment. Apply a thin layer of Bionect without extensive rubbing onto the wound surface, two or three times per day. Cover the lesion area with a sterile gauze pad and, if necessary, with an elastic or compressive bandage.

Warning

If conditions worsens, consult your physician immediately. Keep this product out of the reach of children. The prolonged use of the product may give rise to sensitization phenomena. Should this happen, discontinue the treatment and follow a suitable therapy. Do not use the product after expiration date reported on the package.

Ingredients

Hyaluronic acid sodium salt (Hyalastine), polyethyleneglycol 400 monostearate, decyl ester of oleic, emulsifying wax, glycerol, sorbitol solution 70%, sodium dehydroacetate, methylparaben, propylparaben, fragrance, purified water.

Contraindication

Do not administer to patients with known hypersensitivity to this product.

Drug Interactions

Do not use concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence. The concomitant topical treatment of wounds with antibiotics or other local agents has never given rise to interactions or incompatibilities with Bionect.

Precautions

Each tube of Bionect should be used by one patient only in order to reduce the risk of cross infection.

Adverse Reactions

All suspected adverse reactions occurring during the treatment with Bionect should be reported to your doctor.

How Supplied

Bionect Cream is supplied in a:

25g cream Tube - NHRIC 68712-0007-02

50g Cream Tube - NHRIC 68712-0007-03

60g Cream Tube - NHRIC 68712-0007-04

Manufactured for: Inncoutis Holdings LLC, Charleston SC 29401

1-800-499-4468 www.Innocutis.com, www.Bionect.com

Manufactured by: Fidia Farmacutici S.p.A, Italy

U.S. Pat. No.: 5,925,626

Storage

Please store Bionect at room temperature. Bionect Cream may be stored for up to 24 months.

Carton

INGREDIENTS AND APPEARANCE

BIONECT 
dressing, wound and burn, hydrogel w/drug and/or biologic

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:68712-007

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)	.2 g  in 1 g
PEG-8 STEARATE (UNII: 2P9L47VI5E)
DECYL OLEATE (UNII: ZGR06DO97T)
WHITE WAX (UNII: 7G1J5DA97F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITOL (UNII: 506T60A25R)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:68712-007-01	3 g in 1 TUBE
2	NHRIC:68712-007-02	25 g in 1 TUBE
3	NHRIC:68712-007-03	50 g in 1 TUBE
4	NHRIC:68712-007-04	100 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K963004	04/01/2004

Labeler - Innocutis Holdings LLC (451549861)