FDA Label for Synedent Flx
View Indications, Usage & Precautions
Synedent Flx Product Label
The following document was submitted to the FDA by the labeler of this product Synedgen Inc.. 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.
Drug Facts
Active Ingredients
Sodium fluoride 0.05% (0.02% fluoride ion)
Purpose Anticavity
Use Aids in the prevention of dental cavities
Warnings
Keep out of reach of children.
If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing.
Directions
Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) of rinse between your teeth for 1 minute 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.
Inactive Ingredients
Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide
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Active Ingredients
Sodium fluoride 0.05%
(0.02% w/v fluoride ion)
Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
If more than indicates is swallowed, get medical attention or contact Poison Control Center right away.
Contains shellfish derivatives.
Not to be used by pets.
Do not use if safety seal is broken or missing.
Directions
Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) of rinse between your teeth for 1 minute 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.
Inactive Ingredients
Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Labels
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