- Description
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Ingredients
Aloe acetylated mannan polysaccharide, Aloe acetylated mannan polysaccharide high molecular weight, Carbomer 940, Citric acid, Disodium EDTA, DL-Panthenol, Imidazolidinyl urea, L-glutamic acid, Methylparaben, Potassium sorbate, Purified water, PVP, Sodium benzoate, Sodium chloride, Sodium metabisulfite, Triethanolamine.
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Summary of Safety and Effectiveness
The product is for topical use. The safety of the gel was established through standard biocompatibility tests. These biocompatibility tests were conducted in standard animal models with preparation of the VASCUDERM Hydrogel Wound Dressing. These tests included Primary Dermal Irritation testing and Primary Eye Irritation testing. These studies demonstrated that Vascuderm hydrogel are not primary dermal irritants or primary eye irritants. These studies were conducted in conformance with Good Laboratory Practices (GLP) regulations of the United States Food and Drug Administration (21 CFR, Part 58).
Clinical experience to date has been grained during the course of two studies that involved four patients with radiation dermatitis and 30 with diabetic ulcers. Grades III or IV disbetic ulcers of the foot were treated with VASCUDERM Hydrogel Wound Dressing for 10 weeks. Acute and subacute radiation dermatitis was treated for various times with VASCUDERM Hydrogel Wound Dressing. These studies evaluated the acceptablity of VASCUDERM Hydrogel Wound Dressing to both patients and clinicians, to wound and skin appearance, and to the wound healing environment. These studies concluded that VASCUDERM Hydrogel Wound Dressing is safe and effective for its intended use.
- Indications
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Directions for Use
Flush wound with a suitable wound cleanser. Pat wound dry before applying VASCUDERM Hydrogel Wound Dressing. Apply sufficient amount of VASCUDERM Hydrogel Wound Dressing to cover area, including wound margins. Apply as often as needed. If gauze is used as a wound covering, it should be moistened with a suitable wound cleanser as recommended by a physician.
This product may turn amber in color, a natural phenomenon having no impact on efficacy. Intended for single patient use only.
PRECAUTION: Reduce the possibility of contamination by restricting use of each individual tube of VASCUDERM Hydrogel Wound Dressing to only one patient.
- Warnings
- Adverse Reactions
- How Supplied
- Storage
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
VASCUDERM HYDROGEL WOUND DRESSING
dressing,wound,hydrogel w/out drug and/or biologicProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:68040-751 Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ACEMANNAN (UNII: UZ29E6L2X8) INGR ACEMANNAN (80000 MW) (UNII: N2CFZ4168Y) INGR CARBOMER 940 (UNII: 4Q93RCW27E) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR IMIDUREA (UNII: M629807ATL) INGR GLUTAMIC ACID (UNII: 3KX376GY7L) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR WATER (UNII: 059QF0KO0R) INGR POVIDONE (UNII: FZ989GH94E) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68040-751-35 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K960428 09/01/2014 Labeler - Primus Pharmaceuticals, Inc (130834745) Establishment Name Address ID/FEI Business Operations Medline Industries, Inc 025460908 manufacture