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MedActive Patient Friendly by Integrate Oral Care, LLC.

Medically reviewed on Nov 20, 2017

Dosage form: kit
Ingredients: STANNOUS FLUORIDE 6.3mg in 1mL;
Labeler: Integrate Oral Care, LLC.
NDC Code: 49741-1007

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.

Active ingredient

Stannous fluoride 0.1%

Purpose

Cavity protection

Uses

  • Aids in the prevention of dental decay.

Warnings

  • When using this product, do not use longer than four weeks unless recommended by a medical doctor and/or dental professional.
  • If more than used for rinsing is swallowed, seek medical attention or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

Use immediately after preparing the rinse as follows:

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 the cap. Dispense half of mixture into the 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.

Children under 6 years of age:

  • Consult your medical doctor and/or dental professional

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 dental professional.
  • Do not refrigerate. Store at room temperature.

Inactive Ingredients

dimethicone, EDTA, FD&C Green No. 3, flavor (includes Spilathes Extract), glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbitol, sucralose, water

Questions or comments?

1-866-877-4867 M-F 9am-5pm EST or www.medactive.com

MedActive® Oral Care Redefined™

Patient-Friendly™ Ruby Raspberry

Stannous Fluoride Rinse with ULTRAMULSION® & Spilanthes Extract

10 DOSE PACKS

IMPORTANT Read directions for proper use.

NET CONTENTS: 10 DOSE PACKS 10.4 FL OX (307 mL)

NDC 49741-1007-2

MedActive® Oral Care Redefined™

Patient-Friendly™ Ruby Raspberry

Stannous Fluoride Rinse with ULTRAMULSION® & Spilanthes Extract

30 DOSE PACKS

IMPORTANT: Read directions for proper use.

NDC 49741-1007-3

MEDACTIVE PATIENT FRIENDLY 
stannous fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1007
Packaging
#Item CodePackage Description
1NDC:49741-1007-210 CARTON in 1 BOX
1NDC:49741-1007-11 KIT in 1 CARTON
2NDC:49741-1007-330 CARTON in 1 BOX
21 KIT in 1 CARTON
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 31 mL  in 1 mL
GLYCERIN1 mL  in 1 mL
Packaging
#Item CodePackage Description
13.7 mL in 1 KIT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/31/2014
Part 2 of 2
CHAMBER NO. 2 
stannous fluoride diluent emulsion
Product Information
Route of AdministrationORALDEA Schedule    
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
SORBITOL 
DIMETHICONE 
POTASSIUM SORBATE 
POLOXAMER 407 
SUCRALOSE 
WATER 
EDETIC ACID 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY (Ruby Raspberry with ULTRAMULSION & Spilanthes Extract) Imprint Code
Contains    
Packaging
#Item CodePackage Description
127 mL in 1 KIT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/31/2014
Labeler - Integrate Oral Care, LLC. (063540457)
Registrant - Integrate Oral Care, LLC. (063540457)

 
Integrate Oral Care, LLC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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