Label: FRAICHE STANNOUS FLUORIDE RINSE, SPEARMINT FLAVOR- stannous fluoride liquid
- NDC Code(s): 83592-800-04
- Packager: True Marker Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 16, 2024
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- Official Label (Printer Friendly)
- Active Ingredient (s)
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
• Do not use before mixing with water.
• Adults and children 6 years of age and older:
• Use once a day after brushing your teeth with a toothpaste.
• Open the bottle by twisting the cap counter clockwise.
• Pour 1/8 fl. oz. into a cup. Add water to line (1 fl. oz.) on cup.
• Mix using bristle end of toothbrush.
• Vigorously swish rinse between your teeth for 1 min. and then spit out.
• Do not swallow the rinse.
• Do not eat or drink for 30 min. after rinsing.
• Instruct children under 12 in good rinsing habits to minimize swallowing.Supervise children as necessary until capable of usingwithout supervision.
• Children under 6: Consult a dentist or doctor.
- Other information
- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
FRAICHE STANNOUS FLUORIDE RINSE, SPEARMINT FLAVOR
stannous fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83592-800 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.63 mg in 100 mL Inactive Ingredients Ingredient Name Strength EDETIC ACID (UNII: 9G34HU7RV0) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83592-800-04 1 in 1 CARTON 04/04/2024 1 118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 04/04/2024 Labeler - True Marker Pharmaceuticals, Inc. (119046582)