Sonafine Wound Dressing

TOPICAL EMULSION DRESSING

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.

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

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.

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.

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.

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

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.

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

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

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:
Sonar Products Inc
Carlstadt, NJ 07072

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

STRATUS
PHARMACEUTICALS INC
NDC 58980-960-31
Net WT. 90g

SONAFINE™ WOUND DRESSING
TOPICAL EMULSION DRESSING

Rx only

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