FDA Label for Sodium Fluoride
View Indications, Usage & Precautions
Sodium Fluoride Product Label
The following document was submitted to the FDA by the labeler of this product Vi-jon. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium fluoride 0.02% (0.01% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warning
for this product
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately
Directions
Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 miute and then spit out.
- 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 supervision
- children under 6 years of age: consult a dentist or doctor
Other Information
- store at room temperature 20⁰-25⁰ C (68⁰-77⁰ F)
- cold weather may temporarily cloud this product
Inactive Ingredients
water, sorbitol solution, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1
Principal Display Panel
Anticavity Mouthwash
IMPORTANT: Read directions for proper use.
33.8 FL OZ (1 L)
971.000/971AA
* Please review the disclaimer below.