STANCE- 0.63% stannous fluoride concentrate rinse rinse

Stance by

Drug Labeling and Warnings

Stance by is a Otc medication manufactured, distributed, or labeled by Elevate Oral Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 CHILDREN

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

PURPOSE

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

INGREDIENTS AND APPEARANCE

STANCE 
0.63% stannous fluoride concentrate rinse rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57511-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape	ROUND	Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57511-0201-1	225 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/25/2016

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Establishment
Name	Address	ID/FEI	Business Operations
Elevate Oral Care		002863526	repack(57511-0201)