MEDACTIVE PATIENT FRIENDLY- stannous fluoride kit

MedActive Patient Friendly by

Drug Labeling and Warnings

MedActive Patient Friendly by is a Otc medication manufactured, distributed, or labeled by Integrate Oral Care, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Stannous fluoride 0.1%

PURPOSE

Purpose

Cavity protection

INDICATIONS & USAGE

Uses

• Aids in the prevention of dental decay.

WARNINGS

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

Inactive Ingredients

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

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

MEDACTIVE PATIENT FRIENDLY 
stannous fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49741-1007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49741-1007-2	10 in 1 BOX	07/31/2014
1	NDC: 49741-1007-1	1 in 1 CARTON; Type 0: Not a Combination Product
2	NDC: 49741-1007-3	30 in 1 BOX	07/31/2014
2		1 in 1 CARTON; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 KIT	3.7 mL
Part 2	1 KIT	27 mL

Part 1 of 2

CHAMBER NO. 1 
stannous fluoride concentrate

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	6.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)	1 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.7 mL in 1 KIT; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/31/2014

Part 2 of 2

CHAMBER NO. 2 
stannous fluoride diluent emulsion

Product Information
Route of Administration	ORAL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		27 mL in 1 KIT; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/31/2014

Labeler - Integrate Oral Care, LLC. (063540457)

Registrant - Integrate Oral Care, LLC. (063540457)