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Stance by Elevate Oral Care

Medically reviewed on January 31, 2018.

Dosage form: rinse
Ingredients: STANNOUS FLUORIDE 0.63mg in 1mg
Labeler: Elevate Oral Care
NDC Code: 57511-0201

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.

Stance 0.63% Stannous Fluoride Concintrate Rinse

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.63% Rinse Concentrate

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.

Keep out of reach of infants and children.

INSTRUCTIONS FOR USE SECTION

Directions

Adults and 6 years of age 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 of age
• 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

Dosage and Administration

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% Rince Concentrate

STANCE 
0.63% stannous fluoride rinse concentrate rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.63 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XYLITOL 
Product Characteristics
Color    Score    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57511-0201-1283500 mg in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/25/2016
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIOperations
Elevate Oral Care002863526repack(57511-0201)

 
Elevate Oral Care

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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