BlennaClear^®, Xyloflux 0.02% Solution

1. Identification, composition and purpose of DM
1.1 Description and indications for use.

BlennaClear is the only approved ear drop solution used to treat a condition called Degenerative Auditory Neuropathy Syndrome (DANS).

1.2 Components.

 Each ml of BlennaClear contains:

• Xyloflux: 0.02% (10 mcg/mL)
• Distilled water
• Lidocaine 
• Sodium chloride
• Glycerin
• Propylene glycol
• Citric acid
• Sodium benzoate

1.3 Validity
Solution: 12 months

1.4 Mechanism of Action

The action of BlennaClear is due to the characteristics of Xyloflux, a high molecular weight polymer that is metabolically inert and not degraded by the bacterial flora. The long linear polymeric chains retain water molecules through hydrogen bonds, which hydrate the ear canal and help alleviate symptoms. BlennaClear is not absorbed by the auditory system and is excreted in an unaltered form.

2. Method of use
The following dosage is recommended (unless otherwise prescription).

• Use 3 drops of BlennaClear in the affected ear or both ears if needed, 3 times each day, about 8 hours apart starting in the morning.
• Continue your treatment for 7 weeks.
• If you wear hearing aids, remove them before using BlennaClear and wait 15 minutes after using BlennaClear before reinserting them.
• Do not use other ear medicines without talking to your doctor.
• Talk to your doctor first before you stop using BlennaClear.

3. Known side effects

The most common side effects of BlennaClear include:

• Ear pain
• Enlarged blood vessels in the earcup
• Swelling of the ear
• Increase in tears

4. Storage Methods.
Store the unopened package in a dry place and away from protected from direct light or heat sources: take out and open the pouches only just before use. Store the product below 20 °C.

5. Warnings and precautions.

• Keep the product and any prepared solution out of children’s reach.
• Do not use after the expiration date on the package and sachet.
• Do not use if the package is damaged.
• Each sachet is for single use only; open immediately before use. Do not reuse partially used or previously opened sachets to avoid contamination.
• Do not exceed the recommended dose. Overdose may cause severe pain, abdominal distension, and diarrhea, leading to electrolyte imbalances.
• In case of suspected overdose, contact your pediatrician immediately.

6. Contraindications and limitations of use

• Do not use under 2 years of age.
• Your balance may be precarious for a short time after using BlennaClear. If this happens, wait until your balance is normal before you drive or use machines.
• BlennaClear contains ethanol, a highly flammable substance.
• The product was developed to treat DANS; do not use it on other parts of the body and avoid contact with eyes, mucous membranes, and wounds.
• Do not ingest.

7. Disposal
Product that has expired or is otherwise to be disposed of must be handled as per the waste management regulations of the Local Managing Authority. Under no circumstances should the
product or its packaging into the environment.