Label: PROXIVOL-

  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated February 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Proxivol is a soothing wound gel that promotes a moist wound environment that is ideal for the healing process.

  • Directions:

    Cleanse wound then apply Proxivol to the wound and skin surrounding the wound 3 - 4 times daily.

  • Indications:

    For the local management of painful skin wounds, including:
    • Pressure ulcers
    • Venus stasis ulcers
    • Superficial wounds and scrapes
    • 1st and 2nd degree burns

  • Warnings:

    External use only. Do not use this product if you are allergic to any of the ingredients. Avoid contact with eyes. Sterile unless opened or damaged.

  • Caution:

    Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

  • Storage:

    Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

  • Ingredients:

    Water, Lidocaine HCl, Collagen, Aloe Vera gel, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

  • CALL YOUR DOCTOR ABOUT SIDE EFFECTS:

    Call your doctor about side effects. You may report side effects to Misemer Pharmaceutical at 1-662-993-9625 or the FDA at 1-800-FDA-1088.

  • How Supplied:

    Proxivol wound gel is supplied as a gel in:
    1 oz. (28.33g) tube, NDC 0276-0603-28

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Misemer Pharmaceutical
    Ripley, MS 38663

    Item 0603

    Rev 1021

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PROXIVOL 
    dressing, wound and burn, hydrogel w/drug and/or biologic
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:0276-0603
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A)  
    BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    Product Characteristics
    (SPLSTERILEUSE)false
    (SPLMRISAFE)true
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0276-0603-2828.33 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK02054002/01/2022
    Labeler - Misemer Pharmaceutical (784121365)
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