PROXIVOL- dressing, wound and burn, hydrogel w/drug and/or biologic    
Misemer Pharmaceutical

----------

Proxivol

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

Distributed By:
Misemer Pharmaceutical
Ripley, MS 38663

Item 0603

Rev 1021

image description

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)

Revised: 2/2022
Document Id: 7cf8d5d6-cc43-43fb-be16-3ca156c981da
Set id: 9d4635fd-34db-4375-8e08-9f0a4de66162
Version: 1
Effective Time: 20220201
 
Misemer Pharmaceutical