FRAICHE STANNOUS FLUORIDE RINSE, FRUIT PUNCH FLAVOR- stannous fluoride liquid

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]

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.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

FRAICHE STANNOUS FLUORIDE RINSE, FRUIT PUNCH FLAVOR 
stannous fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83592-801
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: 83592-801-04	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)