Otc - Active Ingredient Section
Stannous Fluoride 0.63% Rinse Concentrate
Stance Rinse
FDA Label NDC 57511-0201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elevate Oral Care for the product Stance (NDC 57511-0201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient section, indications & usage section, warnings section, otc - keep out of reach of children, instructions for use section, inactive ingredient section, otc - questions section, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Otc - 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
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