FDA Label for Plaque Refresh Remineralizing Rinse Fresh Mint

View Indications, Usage & Precautions

Plaque Refresh Remineralizing Rinse Fresh Mint Product Label

The following document was submitted to the FDA by the labeler of this product Tja Health Llc. 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


Keep Out Of Reach Of Children.



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



- Adults and children 12 years of age or older:
- use twice daily after brushing your teeth
- vigorously swish 10 mL (2 teaspoonfuls) 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
- supervise children as necessary
- Children under 12 year of age: consult a dentist or doctor


Other Information



- store at room temperature
- cold weather may temporarily cloud this product


Inactive Ingredients



Water, sorbitol, vegetable glycerin, xylitol, poloxamer-407, polysorbate-20, sodium bicarbonate (baking soda), aloe barbadensis leaf juice extract, persea gratissima (avocado) oil, tocopherol acetate (natural vitamin E), mentha viridis (spearmint) leaf oil, mentha piperita (peppermint) oil, melaleuca alternifolia (tea tree) leaf oil, citrus paradisi (grapefruit) seed oil, eucalyptus globulus leaf oil, menthol, thymol, gaultheria procumbens (wintergreen) leaf oil, bixa orellana (annatto) seed extract, PVP, calcium lactate, tetrasodium pyrophosphate, sodium  hexametaphosphate, blue no.1, zinc citrate, sodium benzoate, sodium gluconate, phosphoric acid, cellulose gum, disodium EDTA.


Package Labeling:




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