VASCUDERM HYDROGEL WOUND DRESSING () [PRIMUS PHARMACEUTICALS, INC]

VASCUDERM HYDROGEL WOUND DRESSING () [PRIMUS PHARMACEUTICALS, INC]
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NDC 68040-751-35
Set ID 629ce007-225f-49d9-a77e-ec82afc252b7
Category MEDICAL DEVICE
Packager Primus Pharmaceuticals, Inc
Generic Name
Product Class
Product Number
Application Number K960428
  • Description

    VASCUDERM Hydrogelgel Wound Dressing is a non-oily hydrogel intended for the management of wounds.

  • 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.

  • 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

    VASCUDERM Hydrogel Wound Dressing is indicated for use in the management of: Stasis Ulcers, Foot Ulcers, Diabetic Ulcers, Pressure Ulcers, Surgical Incisions, Skin Conditions associated with Peristomal Care, Cuts and Abrasions, First and Second Degree Burns, Radiation Dermatitis, and Sunburn.

  • 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

    If condition worsens or does not improve within 10-14 days, consult a physician.  Keep this and all similar products out of the reach of children. Discontinue use if sensitivity occurs.

  • Adverse Reactions

    Sensitivity to VASCUDERM Hydrogel Wound Dressing is infrequent.  If a reaction is observed, discontinue use and consult a physician.  Consult a physician for assistance with wounds that do not heal normally.

  • How Supplied

     Package # Description
     68040-751-35 85 gram tube
     68040-751-04 5 gram pouch sample - ​not for resale

    Each 5 gram sample pouch contains multiple doses depending on the surface area treated.

  • ​Storage

    Store in a dry place and at room temerature.

  • ​Principal Display Panel

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    VASCUDERM HYDROGEL WOUND DRESSING 
    dressing,wound,hydrogel w/out drug and/or biologic
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:68040-751
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRACEMANNAN (UNII: UZ29E6L2X8)  
    INGRACEMANNAN (80000 MW) (UNII: N2CFZ4168Y)  
    INGRCARBOMER 940 (UNII: 4Q93RCW27E)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRIMIDUREA (UNII: M629807ATL)  
    INGRGLUTAMIC ACID (UNII: 3KX376GY7L)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOVIDONE (UNII: FZ989GH94E)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68040-751-3585 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK96042809/01/2014
    Labeler - Primus Pharmaceuticals, Inc (130834745)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medline Industries, Inc025460908manufacture