Label: STANCE- 0.63% stannous fluoride concentrate rinse rinse
- NDC Code(s): 57511-0201-1
- Packager: Elevate Oral Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- INDICATIONS & USAGE SECTION
-
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
-
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 supervisionChildren under 6 years of age
• consult a dentist or doctor - INACTIVE INGREDIENT SECTION
- OTC - QUESTIONS SECTION
- Dosage and Administration
- PURPOSE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
STANCE
0.63% stannous fluoride concentrate rinse rinseProduct 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 Drug M021 08/25/2016 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 manufacture(57511-0201)
