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Stance

Medically reviewed by Drugs.com. Last updated on Jan 23, 2020.

Dosage form: rinse
Ingredients: STANNOUS FLUORIDE 1.2mg in 1mL
Labeler: Elevate Oral Care
NDC Code: 57511-0201

Stance 0.63% Stannous Fluoride Concentrate Rinse Mint

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 concentrate rinse 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 ION1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XYLITOL 
Product Characteristics
Color    Score    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57511-0201-1225 mL 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

Further information

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