Label: SONAFINE WOUND DRESSING- emulsion

  • NHRIC Code(s): 58980-960-12, 58980-960-31
  • Packager: Stratus Pharmaceuticals
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated October 20, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    TOPICAL EMULSION DRESSING

  • Description

    SONAFINE™ WOUND DRESSING is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound SONAFINE™ WOUND DRESSING provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

  • Indications and Usage

    SONAFINE™ WOUND DRESSING is indicated for use in: Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers, Superficial Wounds, 1st and 2nd Degree Burns, Including Sunburns, Dermal Donor and Graft Site Management, Radiation Dermatitis and Minor Abrasions

  • Contraindications

    SONAFINE™ WOUND DRESSING is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies and when an allergy to one of the ingredients is known.

  • Warnings

    In radiation therapy SONAFINE™ WOUND DRESSING may be applied as directed by the treating physician. Do not apply 4 hours prior to a radiation session.

    Do not apply SONAFINE™ WOUND DRESSING to dermal grafts until after the graft has successfully taken.

    Keep out of the reach of children.

  • Precautions and Observations

    For the treatment of any dermal wound, consult a physician. Use SONAFINE™ WOUND DRESSING only as directed.

    SONAFINE™ WOUND DRESSING is nontoxic, it is for topical use only and should not be ingested or taken internally.

    SONAFINE™ WOUND DRESSING does not contain a sunscreen and should not be used prior to extended exposure to the sun.

    The use of SONAFINE™ WOUND DRESSING on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended.

    Following the application of SONAFINE™ WOUND DRESSING a temporary tingling sensation may occur (10 to 15 minutes). If clinically indicated, use of SONAFINE™ WOUND DRESSING may be continued during the anti-infective therapy.

    If the condition does not improve within 10-14 days, consult a physician.

    SONAFINE™ WOUND DRESSING may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

  • Instructions for Use

    SONAFINE™ WOUND DRESSING is for topical use only as directed by a healthcare professional.

    Wounds, Abrasions, Full Thickness Wounds, Dermal Graft Site Management and Donor Site Management

    Wash the affected area(s) with saline, clean water or suitable wound cleanser.

    Apply SONAFINE™ WOUND DRESSING on and around the affected area(s) in thick layers ¼ to ½ inch thick.

    If applying gauze dressing, moisten the dressing lightly before application.

    Reapply SONAFINE™ WOUND DRESSING as described above every 24 to 48 hours or as directed until the wound or lesion has healed fully.

    For donor site management, apply SONAFINE™ WOUND DRESSING after skin removal and cover with a moist dressing. Reapply as directed.

    For dermal graft site management apply SONAFINE™ WOUND DRESSING to the graft site only after the graft has taken successfully. SONAFINE™ WOUND DRESSING can be washed away with a saline solution or clean water without causing damage to the newly formed tissues.

    1st and 2nd Degree Burns Including Sunburns

    Before any application of SONAFINE™ WOUND DRESSING to burns take precaution in removing any clothing in the affected area(s).

    Apply SONAFINE™ WOUND DRESSING as soon as possible on and around the affected area(s) in a thick ¼ to ½ inch layer until the skin no longer absorbs the product. A white waxy residue may remain. If pain from the burn persists, apply thinner layers of SONAFINE™ WOUND DRESSING until the pain has ceased.

    Continue to apply SONAFINE™ WOUND DRESSING until the affected area(s) has healed completely.

    Application of SONAFINE™ WOUND DRESSING to the affected area(s) should continue during any subsequent physical therapy treatments.

    Radiation Dermatitis

    Apply a generous amount of SONAFINE™ WOUND DRESSING three times per day, seven days a week to the treated area(s), gently massaging the area(s) until SONAFINE™ WOUND DRESSING is completely absorbed.

    SONAFINE™ WOUND DRESSING may be applied as indicated by the treating physician (see Warnings).

    Continue to apply SONAFINE™ WOUND DRESSING as described above until the skin has fully recovered.

    Do not interrupt applications during the course of radiation therapy, even for one day.

    Do not apply SONAFINE™ WOUND DRESSING 4 hours prior to a radiation session.

  • Ingredients

    SONAFINE™ WOUND DRESSING contains avocado oil, cetyl palmitate, ethylene glycol monostearate, fragance, liquid paraffin, methyl paraben, paraffin wax, propylene glycol, propyl paraben, purified water, sodium alginate, sodium hydroxide, sorbic acid (potassium salt), squalane, stearic acid and trolamine.

  • How Supplied

    SONAFINE™ WOUND DRESSING is supplied in tubes in the following sizes:

    45gram tube, NDC# 58980-960-12
    90gram tube, NDC# 58980-960-31

    Store at room temperature, do not freeze.

  • SPL UNCLASSIFIED SECTION

    Rx ONLY- Prescription Medical Device: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

    Manufactured by:
    Tarmac Products Inc
    Miami Gardens, FL 33014

    Distributed by:
    Stratus Pharmaceuticals Inc
    12379 SW 130th Street
    Miami, FL 33186

    For additional information:
    Contact Customer Service at:
    Toll Free - 1-800-442-7882

    www.stratuspharmaceuticals.com

    JG-SWDIN-I2015-04

  • PRINCIPAL DISPLAY PANEL - 90 g Tube Box

    STRATUS
    PHARMACEUTICALS INC

    NDC 58980-960-31
    NET WT. 90g

    SONAFINE™ WOUND DRESSING
    TOPICAL EMULSION DRESSING

    Rx only

    PRINCIPAL DISPLAY PANEL - 90 g Tube Box
  • INGREDIENTS AND APPEARANCE
    SONAFINE WOUND DRESSING 
    dressing, wound, drug emulsion
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58980-960
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Squalane (UNII: GW89575KF9)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Glycol Stearate (UNII: 0324G66D0E)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Alginate (UNII: C269C4G2ZQ)  
    Trolamine (UNII: 9O3K93S3TK)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:58980-960-121 in 1 BOX
    145 g in 1 TUBE; Type 0: Not a Combination Product
    2NHRIC:58980-960-311 in 1 BOX
    290 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    PREMARKET NOTIFICATIONK11017208/19/2011
    Labeler - Stratus Pharmaceuticals (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE, LABEL, PACK
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!