FDA Label for Just Right
View Indications, Usage & Precautions
Just Right Product Label
The following document was submitted to the FDA by the labeler of this product Elevate Oral Care. 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.
Otc - Active Ingredient Section
Sodium Fluoride 0.243% (0.15% w/v fluoride ion) Anticavity
Indications & Usage Section
helps protect against cavities
Warnings Section
Keep out of reach of children under 6 years of age: if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children under 6 years of age:
Instructions For Use Section
Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.35 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
Inactive Ingredient Section
Inactive ingredients; sorbitol, water, glycerin, hydrated silica, PEG-8, FD&C Red 40, sodium lauryl sulfate, potassium phosphate monobasic, xanthan gum, flavor, sodium saccharin, sodium benzoate, mica
Otc - Questions Section
Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
Otc - Purpose Section
Helps protect against Cavities
Dosage & Administration Section
Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.35 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.
Package Label.Principal Display Panel
Just RIght Fluoride Toothapste Cavity Protection. 6 month dosing system. Berry Blast. Net Wt 3.3oz (93.3g)
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