Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

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Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

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Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

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Advisory information

contraindications
Do not smoke during the fluoride treatment. Avoid eating or drinking while wearing the film. Flush with copious amounts of water if accidentally placed in eye. Keep out of reach of young children. Not for use by children under the age of 12. Avoid contact with clothing. Do not use if you have a known allergy to fluoride. Do not wear for more than 15 minutes in a 24 hour period.
Special warnings and precautions
Attention - Refer to the instructions for use and complete information. Use only as directed. Keep out of reach of small children and animals. Storage Temperature - Store product at the indicated temperature (32°F/0°C to 100°F/38°C).

Usage information

Dosing and administration
Separate the paper layer from the plastic tray by pulling where indicated. The sticky gel side is against the plastic layer. Remove shrink wrap from tray. Carefully remove film from tray. The sticky gel side faces up. Position the film so it is centered on the arch. Firmly apply the film to the teeth, with the edge of the film just extending onto the gums. Starting at the front teeth, wrap the film around the edge of the teeth and onto the back side of the teeth. Use your fingers to firmly mold the film to your teeth. Leave the film in place for 15 minutes. DO NOT wear for more than 15 minutes in a 24 hour period. Grasp corner of film and begin to loosen away from teeth. If film becomes difficult to remove, rinse with water. Continue removing film from all surfaces. The film may come away in pieces; this is normal. Brush teeth and gums to remove any remaining gel.

More information

Category Value
Agency product number 8ZYQ1474W7
Orphan designation No
Product NDC 14060-005
Date Last Revised 08-10-2010
Type HUMAN PRESCRIPTION DRUG
Storage and handling Do not store above 100°F (38°C). Do not freeze. Do not use beyond indicated shelf life. Do not use if the packaging has been damaged, or if the seals are found to be broken or open.
Marketing authorisation holder CAO Group, Inc.