MEDACTIVE PATIENT FRIENDLY  - stannous fluoride   
MedActive Oral Pharmaceuticals, LLC.

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Drug Facts

Active Ingredient

Stannous Fluoride 0.63%

Purpose

Remineralizes and strengthens tooth surfaces and aids in the prevention of dental decay.

Keep out of the reach of children under age 6.

• If more than used for rinsing is accidentally swallowed, seek medical attention or contact a Poison Control Center immediately.
  

Uses

• Remineralizes and strengths tooth surface.
• Cleans, lubricates, moistens and protects oral cavity.
• Aids in the prevention of dental decay.
• Builds increasing protection against tooth sensitivity.
  

Other Information

• This product may produce surface staining of the teeth.  Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
• Do not refrigerate.  Store at room temperature.
• See box for expiration date.
  

Directions

• Use immediately after preparing the rinse.

For adults and children 6 years of age and older:

• Place both thumbs on Blue Chamber No. 1 and Press down firmly to squeeze fluoride into Chamber No. 2.
• Gently Shake.
• Snap Tab to Open by bending at line on cap.  Dispense half of mixture into mouth and Rinse for 30 seconds.  Spit.
• Gargle with remainder of mixture for 30 seconds.  Spit.
• Avoid any food or drinks for at least 15 minutes after use.

For children under 6 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, Sorbitol, Glycerin, ULTRAMULSION®, Potassium Sorbate, EDTA, Sucralose, Flavor.

Ruby Raspberry with ULTRAMULSION® and Spilanthes Extract
ALCOHOL-FREE

MEDActive®
Patient-Friendly™
Oral Rinse
with 0.63% Stannous Fluoride
For Relief of Discomfort

IMPORTANT: Read directions for proper use.            Net Contents: 10 Dose Packs, 10.4 FL OZ (307 mL)

MEDACTIVE PATIENT FRIENDLY  stannous fluoride   kit

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49741-1002

Packaging # NDC Package Description Multilevel Packaging 1 49741-1002-2 10 CARTON In 1 BOX contains a CARTON (49741-1002-1) 1 49741-1002-1 1 KIT In 1 CARTON This package is contained within the BOX (49741-1002-2)

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 CONTAINER   3.7 mL Part 2 1 CONTAINER   27 mL

Part 1 of 2 CHAMBER NO. 1  stannous fluoride   concentrate

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Stannous Fluoride (Fluoride Ion) Stannous Fluoride 6.3 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Glycerin   FD&C Green No. 3

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 3.7 mL In 1 CONTAINER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/24/2010

Part 2 of 2 CHAMBER NO. 2  stannous fluoride diluent   emulsion

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found

Inactive Ingredients Ingredient Name Strength Water   Sorbitol   Glycerin   Poloxamer 407   Dimethicone   Potassium Sorbate   Edetic Acid   Sucralose

Product Characteristics Color      Score      Shape Size Flavor RASPBERRY (Ruby Raspberry with ULTRAMULSION and Spilanthes Extract) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 27 mL In 1 CONTAINER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/24/2010

Labeler - MedActive Oral Pharmaceuticals, LLC. (830476847)

Revised: 03/2010MedActive Oral Pharmaceuticals, LLC.