Enamelast – 5% Sodium Fluoride Varnish

Enamelast
Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 1.2 mi syringe or in a 0.4 ml unit dose blister pack.

Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Available in four delicious flavors: Walterberry, Orange Cream, Cool Mint, and Bubble Gum

Enamelast Fluoride Varnish will begin to flake off with each brushing.

Enamelast – Directions for Use:

Syringe Delivery

  1. Thoroughly brush teeth, rubber cup polish or wipe teeth with gauze prior to placement.
  2. Remove the Luer Lock Cap from the syringe and securely attach the SoftEZ delivery tip (sold separately).
    NOTE: Enamelast can also be placed on the back of the clinician’s gloved hand or in a dappen dish and applied with a standard brush (sold separately).
  3. Verify flow prior to applying intraorally.
  4. Verify the color and consistency of the product flow before applying by expressing a small amount onto a mixing pad or gauze. Discard any clear liquid that is expressed.
  5. Lightly dry area to be treated.
  6. Using a painting motion, apply a thin smooth layer to as many dry tooth surfaces as possible.

Unit Dose Delivery

  1. Thoroughly brush teeth, rubber cup polish or wipe teeth with gauze prior to placement.
  2. Open blister pack by peeling back and removing foil lid.
  3. Using the disposable delivery brush, lightly stir the varnish.
  4. Lightly dry area to be treated.
  5. Using a painting motion, apply a thin, smooth layer of Enamelast to as many dry tooth surfaces as possible.

NOTE:

  • The brush may be bent up to a 90- degree angle for easier access.

NOTE:

  • Enamelast sets when it contacts with water or saliva. Allow cheeks, lips, and saliva to contact teeth or gently flow cool water over the teeth. For esthetic reasons, encourage patients not to “lick” their teeth for a few minutes after placement.
  • Patients should avoid brushing, flossing and chewing hard, sticky and hot foods for 4—6 hours after treatment.

Precautions and Warnings:

  1. Carefully read and understand all Instructions before using.
  2. Do not use more than half of the 1.2 mL syringe of fluoride varnish per patient per application.
  3. Store at room temperature.
  4. Verify syringe flow prior to applying intraorally. If resistance is met, replace tip ana re-check. Use only recommended tips.
  5. Do not remove cap from the syringe or foil lid from the unit dose until ready to use.
  6. Patient, clinician, and assistant must wear protective eyewear when using this product.
  7. Do not use on patients with ulcerative gingivitis or stomatitis.
  8. Do not use with other topical fluoride treatments the same day and Instruct patient to refrain from using oral fluoride supplements for A (four) days after treatment.
  9. Do not use on patients with a known sensitivity to ingredients Including colophony (kolophonium) and/rosin. If allergic reaction, dermatitis, or rash develops, consult a physician.
  10. In rare instances, edematous swelling has been reported after extensive fluoride varnish treatment and dyspnea has been reported in asthmatic children.
  11. Some patients may experience nausea after application. If nausea persists, thoroughly brush to remove the varnish film.
  12. Syringe tips are for single- use only, to avoid cross contamination.
  13. The prefilled syringes can be used repeatedly. Use Syringe Covers to avoid cross contamination. After use, remove and dispose the Syringe Cover, together with the syringe tip. Re-cap the syringe with the Luer Lock Cap and disinfect the syringe with a disinfecting agent, suitable for medical devices, which has no protein-fixing effect.
  14. Dispose of containers, brushes, tips and empty syringes properly.
  15. Keep out of reach of children.
  16. For professional use only.

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