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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Active Ingredient

Stannous fluoride 0.1%

Purpose

Cavity protection

Uses

Directions

Use immediately after preparing the rinse as follows:

Adults and children 6 years or age and older:

Children under 6 years of age:

Other information

Inactive Ingredients

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

Questions or comments?

1-866-877-4876 M-F 9am-5pm EST or www.integrateoralcare.com

Keep out of reach of children.

Orange Crème with ULTRAMULSION® & Spilanthes ExtractMedActive® Oral Care Redefined

Patient-Friendly™ Orange Crème

Stannous Fluoride Rinse with ULTRAMULSION ® & Spilanthes Extract

10 DOSE PACKS

IMPORTANT

Read directions for proper use.

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

NDC 49741-1005-2

MedActive® Oral Care Redefined

Patient-Friendly™ Orange Crème

Stannous Fluoride Rinse with ULTRAMULSION ® & Spilanthes Extract

30 DOSE PACKS

IMPORTANT

Read directions for proper use.

NET CONTENTS: 30 DOSE PACKS 31.2 FL OZ (923 mL)

NDC 49741-1005-3

Orange Crème with ULTRAMULSION® & Spilanthes Extract

MEDACTIVE PATIENT FRIENDLY 
stannous fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1005
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49741-1005-210 in 1 BOX07/31/2014
1NDC:49741-1005-11 in 1 CARTON; Type 0: Not a Combination Product
2NDC:49741-1005-330 in 1 BOX07/31/2014
21 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 finalpart35507/31/2014
Part 2 of 2
CHAMBER NO. 2 
stannous fluoride diluent emulsion
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETIC ACID (UNII: 9G34HU7RV0)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Crème with ULTRAMULSION® and Spilanthes Extract) 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 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)

Revised: 12/2021
Document Id: d4645068-90cf-054f-e053-2a95a90a5b96
Set id: 18bcb094-6257-4d1d-e054-00144ff88e88
Version: 12
Effective Time: 20211230
 
Integrate Oral Care, LLC.