ACESO AG SILVER SILICONE FOAM WOUND DRESSING-

ACESO Ag Silver Silicone Foam Wound Dressing by

Drug Labeling and Warnings

ACESO Ag Silver Silicone Foam Wound Dressing by is a Other medication manufactured, distributed, or labeled by NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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ACESO Ag, Silicone Silver Foam Dressing, Rx Only ACESO Ag, Silicone Silver Foam Dressing consists of 0.25-0.35mg/cm2 silver ions, and it has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro.

Indications

For prescription use only.
ACESO Ag, Silicone Silver Foam Dressing is indicated for the treatment of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns.

DESCRIPTION

ACESO Ag, is an absorbent Silicone Silver Foam Dressing used for the management of exudative wounds. It provides a physiologically favorable moist wound environment for wound healing. ACESO Ag absorbs excess wound exudate. ACESO Ag uses silver as a preservative to control bacterial growth within the foam dressing.

ACESO Ag, Silicone Silver Foam Dressing provides a physiologically favorable environment that encourages wound healing and conforms to the wound site. It is easy to use, biocompatible and biodegradable. ACESO Ag, supports natural autolysis by rehydrating and softening necrotic tissue and eschar thereby encouraging autolytic debridement. The silver preservative in the dressing controls microbial growth for up to 7 days within the dressing, as demonstrated in vitro.

Product Administration

1. Clean the wound with sterile water or normal saline and dry the surrounding skin gently.

2. Remove the release films to cover the wound according to the wound area. The dressing should overlap
the dry surrounding skin by at least 1-2 cm.
3. The frequency of replacing depends on patient's conditions and the exudates situation, such as every 24 hours or longer, but cannot exceed more than 7 days.
Note: Dressing may be moistened with sterile water or normal saline to ease removal.

Warnings

1. ACESO Silicone Ag Foam Dressing is a single use. Do not reuse.
2. ACESO Silicone Ag Foam Dressing is sterile. Do not use it if the pouch is damaged or opened prior to use.
3. Do not suggest using this product on dry wounds.
4. Do not use ACESO Silicone Ag Foam Dressing together with oxidant, such as hypochlorite solutions or hydrogen peroxide.
5. ACESO Silicone Ag Foam Dressing may cause transient discoloration of the wound bed and surrounding skin. Frequent or prolonged use
of this product may result in permanent discoloration of skin.
6. ACESO Silicone Ag Foam Dressing does not replace the need for systemic therapy or other adequate infection treatment in the event of
clinical infection.
7. Do not use ACESO Silicone Ag Foam Dressing during radiation treatment or examinations, such as X-ray, magnetic resonance imaging
[MRI] ultrasound or diathermy.
8. Avoid contact with electrodes or conductive gels during electronic measurements, such as electrocardiograms [ECG], and
electroencephalograms [EEG].
9. ACESO Silicone Ag Foam Dressing is only used for external use.

CONTRAINDICATIONS

Contraindicated for individuals with a known sensitivity to silver and any other contents of the dressing.

PRECAUTIONS

Cautions
Federal law restricts this device to sale by or on the order of a physician. (Rx Only)
The total maximum amount of silver is 0.35mg/cm2 in wound pad.

How Supplied

ACESO Ag, Silver Silicone Foam Wound Dressings are packaged in 4 sterile bandages per pack.

NDC: 72678-003-01.

Storage and Disposal

1. Please store the product in cool and dry place, and avoid light.

2. Disposal should be handled according to local environmental procedures.

SHELF LIFE: 3 years from date of manufacture.

SPL UNCLASSIFIED SECTION

Manufactured for:
National Bio Green Sciences LLC, Branchburg, NJ
Questions: National Bio Green Sciences, LLC
Call: 1-908-255-4133 or
Email: info@nbgsusa.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACESO AG SILVER SILICONE FOAM WOUND DRESSING 
dressing, wound, drug

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:72678-003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72678-003-01	4 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K170077	07/15/2019

Labeler - NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY (967054623)