FDA Intended Use:

ActCel Soluble Dental Gauze Dressing is intended for use in extraction sites in addition to its application for the management of other operative, postoperative, and traumatic injuries.

ActCel Soluble Dental Gauze Dressing is made from biocompatible regenerated cellulose treated to become water-soluble after use and contains no chemical additives.  By applying the gauze with gentle pressure, it adheres to the wound to form a barrier – thus protecting it from further irritation.  Upon contact with moisture from a socket or other oral surgical condition, the material dissolves and transforms into a gelatinous mass.  It dissolves into glucose and saline within a few days and is safe if swallowed.

Contraindications:

Warning: As a treatment modality for oral and maxillofacial wounds, this material is not approved or intended to be placed in operative sites with primary closure.  There should be access for venting or drainage into the oral or nasal environment.  If used deep in surgical site or injury that will be sutured and sealed such as some impacted third molars, it should be rinsed out after it has performed its designated use and before the wound is closed primarily.

Precautions:

• Read the instructions (below) prior to use.
• Federal law dictates this product should only be used by a doctor.
• This product within the blister pack is sterile unless opened or damaged.
• It is intended for single use only.
• This product should not be used on patients with an allergy to sodium carboxymethyl cellulose (CMC).
• Contact your doctor if there are signs of allergy (itching, rash, burning) or infection. Swelling could be a sign of allergy (anaphylaxis) or possible infection. Either would be a rare occurrence but require treatment for a medical emergency.
• This gauze dressing should not be used in contaminated or infected wounds or sockets.

Instructions for use:

• ActCel Soluble Dental Gauze Dressing should be placed in a socket or should cover a surgery or injury site. It may need to be cut or folded for this purpose.
• It should be placed in the wound dry as it may stick to metal instruments if wet.
  
• It is activated upon contact with the bleeding or injured mucosa.
• An additional piece of gauze may be applied over the initial one if needed.
• Excess gauze dressing material can be picked off the site or it can be rinsed away with sterile water or saline after it has accomplished its purpose.

Packaging and storage:

• ActCel Soluble Dental Gauze Dressing is available in sterile gamma radiated packaging of different sizes.
• Keep in a cool, dry place for maximum shelf-life. The preferred temperature should be between 5 and 40 degrees Centigrade or between 41 and 104 degrees Fahrenheit.
• Shelf-life is three years.