Clinical Care^® Antimicrobial Wound Cleanser/Proprietary Formulation

NDC #46706-226-5 Product Release-1991
NEW!!! Controlled Clinical Evaluation by GM Associates, Inc.

Indications and Usage

Topical, Antimicrobial Cleansing Solution formulated for use in debriding pressure ulcers, minor bums, and severely irritated dermal areas. Gentle emulsification action loosens eschar and necrotic tissue. Proven effective in the elimination of E. Coli, Staphylococcus aureus, Pseudomonas, MRSA, etc. and those organisms which commonly inhibit wound healing. Clinical Care debrides and decontaminates the wound bed wet greater broad spectrum efficacy than topical antibiotic usage and at a significant cost savings. Clinical Care is also excellent for usage in emergency room environments for extremity, buttock, and torso abrasions and lacerations, commonly referred to as "Road Rash". Clinical Care should be used on contaminated wounds in cases of restricted blood supply where systemic antibiotics can not be effective. Infection and bacterial contamination must be eliminated to promote wound healing. Clinical Care can be used to replace the use of saline solution as an irrigation solution. This technology performs a cleansing function (removal of organic materials) as well as a decontamination function.

Clinical Pharmacology

• Premium Grade Amphoteric Surfactant Blend · Electron Donor
• Active Ingredient: Benzethonium Chloride.1%
• OTC Pharmaceutical Category/Listed PDR, 1992
• No Fragrance/No Dyes/Tearless
• 2 Year Shelf Life

Precautions

• Non-Dermal Irritant - Rated mild in ocular tissue testing
• Non-Toxic Solution, No contra-indications

Microbiology

1. Draize Dermal Irritation Test · No dermal irritant.
2. EyeTex/Ocular Safety & Irritation · Rated mild
3. SkinTex/Dermal Irritation Test · Rated mild.
4. Oral Toxicity · Non-Toxic LD50> 15g/Kg of body weight.
5. Hill Top Bio-Labs, Inc./Kligman, Occluded Site/Antimicrobial Efficacy and Irritation on Intact Skin · Microflora inhibited by 99.9% where Clinical Care^® was applied - 24 hour testing.
6. Broad spectrum in vitro action against E.Coli, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomanas, aeruginosa, MRSA, Candida albicans, Aspergillus, K. pneumonia, etc.
7. Clinical Care^® efficacy testing results in higher efficacy percentages than does the active ingredient alone.

Dosage and Administration

Clinical Care^® has been proven to be mild, non-toxic and with no contra-indications in usage. No damage to fibroblast cells. Irrigate wound site utilizing gentle spray action. No rinsing required. Use sterile gauze to gently remove debris and necrotic tissue at the dermal surface. Wound should be left to air dry with a thin application of Barri-Care^® moisture barrier applied to outside edges of wound opening. Care Crème^® should be applied directly to the wound bed to maintain a moist, vitamin enriched wound healing environment. Clinical Care^® and Barri Care^® promote the natural autolytic debridement process. For cases of severe infection, Techni-Care^® should be utilized to decontaminate and cleanse wounds prior to the use of Clinical Care^®.

Mechanism of Action of Clinical Care^®

Available Product Sizes

Product Code	Product	Container Size	Price
C226-4ZEA	Clinical Care	4-Ounce With Sprayer	$16.95
C226-4Z	Clinical Care	4-Ounce With Sprayer/48 per case	$178.00
C226-12ZEA	Clinical Care	12-0unce With Sprayer	$28.95
C226-12Z	Clinical Care	12-0unce With Sprayer/24 per case	$199.00

Podiatric Note

Clinical Care has proved effective for use on calloused areas to soften heavy keratinization prior to surgical removal.

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