MEDACTIVE PATIENT FRIENDLY- stannous fluoride 
Integrate Oral Care, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 strengthens 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

Backimage of rinse box front
Orange Crème with ULTRAMULSION®

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 (307ml)

MEDACTIVE PATIENT FRIENDLY 
stannous fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1003
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49741-1003-210 in 1 BOX02/24/201001/02/2017
1NDC:49741-1003-11 in 1 CARTON; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 KIT 3.7 mL
Part 21 KIT 27 mL
Part 1 of 2
CHAMBER NO. 1 
stannous fluoride concentrate
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 1 mL
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) 1 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13.7 mL in 1 KIT; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/24/2010
Part 2 of 2
CHAMBER NO. 2 
stannous fluoride diluent emulsion
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Crème with ULTRAMULSION) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
127 mL in 1 KIT; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/24/201001/02/2017
Labeler - Integrate Oral Care, LLC. (063540457)

Revised: 12/2017
 
Integrate Oral Care, LLC.