Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor by True Marker Pharmaceuticals, Inc. Drug Facts

Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor by

Drug Labeling and Warnings

Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor by is a Otc medication manufactured, distributed, or labeled by True Marker Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRAICHE STANNOUS FLUORIDE RINSE, FRUIT PUNCH 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

  • helps prevent gingivitis 
  • helps interfere with harmful effects of plaque associated with gingivitis.

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 to the first line (0.159 oz) on cup. Add water to second line (1fl 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

  • Store at room temperature 59-86˚F (15-30˚C)
  • This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Inactive Ingredients

Edetic Acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

Product label

image descriptionimage description

FRAICHE STANNOUS FLUORIDE RINSE, FRUIT PUNCH FLAVOR 
stannous fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83592-801
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: 83592-801-041 in 1 CARTON04/04/202412/01/2024
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 DrugM02104/04/202412/01/2024
Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 11/2024
Document Id: 27eb515c-d888-f1c2-e063-6394a90a2e2a
Set id: 43e25fd7-02f8-4be7-a31c-00d97f6a13c7
Version: 3
Effective Time: 20241127