ACESO Ag Silver iSilicon Foam Wound Dressing

Manufacturer
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
Effective date
2019-08-21
Label type
MEDICAL DEVICE
Version
3
Source
full-release
Hydrated at
2026-06-01 02:49:21

Label at a glance#

ProductACESO Ag Silver Silicone Foam Wound Dressing
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

-----------------------------
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

INDICATIONS & USAGE SECTION

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

DESCRIPTION SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

CONTRAINDICATIONS SECTION

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

PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

NDC 72678-003-01.

Storage and Disposal

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72678-003-01ACESO Ag Silver Silicone Foam Wound Dressing4 in 1 CARTON43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72678-003ACESO AG SILVER SILICONE FOAM WOUND DRESSING () [NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY]31 package rows20190823_ebff5325-d1d3-4f14-b575-9ccf9ab53896.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72678-003-01EA - Each72678-00343941772-7843-4835-bffb-0c69c756f83812019-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72678-00372678-003-01

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.