FRAICHE STANNOUS FLUORIDE RINSE, SPEARMINT FLAVOR- stannous fluoride liquid 
True Marker Pharmaceuticals, Inc.

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Drug Facts

Active Ingredient (s)

Stannous fluoride, 0.63%

Purpose

Anticavity/Antigingivitis

Uses

  Aids in the prevention of dental decay

Warnings

Keep out of reach of children under 6 years of age. If more than used
for rinsing is swallowed, get medical help or contact a Poison Control
Center right away. Do not swallow.

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 using

  without supervision.

• Children under 6: Consult a dentist or doctor.

Other information

Inactive Ingredients

Edetic Acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

Product label

image descriptionimage description

FRAICHE STANNOUS FLUORIDE RINSE, SPEARMINT FLAVOR 
stannous fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83592-800
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.63 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETIC ACID (UNII: 9G34HU7RV0)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83592-800-041 in 1 CARTON04/04/2024
1118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02104/04/2024
Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 4/2024
Document Id: 1637f554-c2e0-9528-e063-6294a90af43b
Set id: 79e562dd-348d-4923-b038-716c06d63984
Version: 1
Effective Time: 20240416
 
True Marker Pharmaceuticals, Inc.