STANCE- 0.63% stannous fluoride concentrate rinse rinse 
Elevate Oral Care

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Stance 0.63% Stannous Fluoride Concentrate Rinse Tropical Breeze

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.63% Concentrate Rinse

INDICATIONS & USAGE SECTION

Uses • aids in the prevention of dental decay
• helps prevent gingivitis • helps control plaque bacteria
• builds increasing protection against painful tooth sensitivity

WARNINGS SECTION

Warnings
• when using this product do not use for sensitivity longer
than four weeks unless recommended by a dentist
• stop use and ask a dentist if sensitivity persists or worsens
because sensitive teeth may indicate a serious problem that
may need prompt care
Keep out of reach of children. If more than used for
rinsing is accidentally swallowed, seek medical attention or
contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of infants and children.

INSTRUCTIONS FOR USE SECTION

Directions

Adults and Children 6 years and older:
• do not use before mixing with water
• use immediately after preparing rinse
• use once daily after brushing your teeth
with a toothpaste or as directed by your dentist
• remove cap and replace with pump
• rotate spout counter clockwise to extend
• depress pump until medicine comes to the tip
of the pump
• make 2 complete pump depressions into cup
provided (1/8 oz)
• add tap water to line (1 oz) on cup
• close cap and shake to mix
• vigorously swish 1/2 oz for one minute then
spit out and repeat with second 1/2 oz
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good
rinsing habits (to minimize swallowing)
• supervise children as necessary until capable
of using without supervision

Children under 6 years:
• consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, xylitol, flavor

OTC - QUESTIONS SECTION

Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com

make 2 complete pump depressions into cup
provided (1/8 oz)
• add tap water to line (1 oz) on cup
• close cap and shake to mix
• vigorously swish 1/2 oz for one minute then
spit out and repeat with second 1/2 oz
• do not swallow the rinse

• aids in the prevention of dental decay
• helps prevent gingivitis • helps control plaque bacteria
• builds increasing protection against painful tooth sensitivity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stannous Fluoride 0.63% Rinse Concentrate label

STANCE 
0.63% stannous fluoride concentrate rinse rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeROUNDSize
FlavorFRUIT (Tropical Breeze) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0202-1225 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02108/25/2016
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0202)

Revised: 10/2023
Document Id: 08f2f8ae-fa68-47c6-e063-6394a90a752f
Set id: 3ae8badf-f960-62fd-e054-00144ff8d46c
Version: 10
Effective Time: 20231030
 
Elevate Oral Care