Humatrix^® Microclysmic Gel for Treatment of Tissue Trauma

NDC #46706-440-04
Patent Pending - New Technology
O-T-C Pharmaceutical/Protectant

Indications and Usage

Humatrix^® Microclysmic Gel exhibits endothermic and biometric properties which cool traumatized tissue and aid in the homeostasis of healing. Humatrix^® Microclysmic Gel provides the ultimate moisturization for burns, autograft procedures, radiation irritation, glycolic acid peel irritation, mechanical injuries, laser treatment, and chronic wound therapy. Advanced biochemical technology provides several unique benefits. First, the time release of water molecules provides the traumatized tissue a consistent level of humectancy to promote tissue regeneration. Secondly, Humatrix^® provides a protein template to assist the biological regeneration of fibroblast cells necessary for wound healing. Thirdly, the cooling process of Humatrix^® lowers the surface temperature 8 to 12 degrees within three minutes preventing further tissue damage caused by dehydration of cells. Humatrix^® Microclysmic Gel is a bacteriostatic, protein enriched formulation designed to maintain a moist, sterile environment which promotes and accelerates cellular regeneration by replicating the natural fibro-connective template and promoting fibroblast activity, the precursor of collagen formulation. The fibron network maintains homeostasis via the product's bio-chemical process by the addition of an analog of extracellular matrix. Humatrix^® assists in the reduction of hyper-granulation, scarring, and hyper-contracture as well as increases both the extensibility and flexibility of human skin with the addition of the glycosaminoglycan matrix. Humatrix^® is an excellent adjunct to wound treatment. Humatrix^® maintains a sterile, moist environment for the healing of chronic and acute wounds by modulating the osmotic pressure of tissue by the timed release of moisture for cellular regeneration.

Clinical Pharmacology

• Proprietary Blend of Humectants and Biological Additives/Protein, Chondroitin Sulfate
• O-T-C Pharmaceutical

Precautions

• External use only.
• Non-toxic.
• No contra-indications.

Microbiology

1. Draize Dermal Irritation • Federal Substance Act (16 CFR) and Food & Drug Administration (21 CFR) - F.D.A. regulated study - Hill Top Biolabs, Inc. - Primary Irritation Index 0.9. No evidence of necrosis - Not classified as a primary irritant.
2. Acute Oral Toxicity • Non-Toxic. LD50 > 5.0g/Kg.
3. Primary Eye Irritation Study • Federal Hazardous Act (16 CFR) and Food and Drug Administration (21 CFR). No evidence of positive corneal, iritic, or conjunctival changes. All irritation scores were zero. No changes were noted to the eyes. No evidence of corrosion was noted. F.D.A. Regulated study, performed by Hill Top Biolabs, Inc. Project Number 94-8442-21. No toxicity.
4. Humatrix^® is a bacteriostatic protectant - no bacteriocidal capacity.

Dosage and Administration

Indicated for burns, autograft procedures, radiation irritation, glycolic acid peel irritation, mechanical injuries, laser treatment, and chronic wound therapy. Cleanse the traumatized tissue with Techni-Care^® Surgical Wound Cleanser. Rinse thoroughly with Clinical Care^® Antimicrobial Wound Cleanser. Do not pat dry. Apply a layer of Humatrix^® Microclysmic Gel approximately 4mm. thick. Cover the wound with a non-occlusive dressing. Reapply at every dressing change to maintain a moist wound environment. Sterile gauze is sufficient wound dressing with this advanced technology. Discontinue all use of topical antibiotics with this therapy protocol.

Available Product Sizes

Product Code	Product	Container Size	Price
C440-8.5ZEA	Humatrix	8.5 ounce	$39.00
C440-8.5Z	Humatrix	8.5 ounce/12 per case	$245.00
C440-2ZEA	Humatrix	1.75 ounce pump bottle	$19.95
C440-2Z	Humatrix	1.75 ounce/12 per case	$170.00

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