FDA Label for Oral7

View Indications, Usage & Precautions

Oral7 Product Label

The following document was submitted to the FDA by the labeler of this product Jcec Company, 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.

Other



Drug Facts


Active Ingredient



Sodium Monofluorophosphate 0.76% w/w (1000ppmF)


Purpose



Anti-cavity


Use



Aids in the prevention of dental cavities.


Otc - Keep Out Of Reach Of Children



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. If symptoms of dry mouth persist, consult a health care professional.


Otc - Do Not Use



DO NOT use if you are allergic to any of the ingredients.


Directions



Adults and Children 2 years of age and older

  • Use 2-3 times a day, 7 days a week.
  • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.


Other Information



Store below 77°F (25°C).


Ingredients



Sorbitol, Dicalcium Phosphate, Glycerin, Hydrated Silica, Dextrose Monohydrate, Silica, Isoceteth-20, Xylitol, Water, Cellulose Gum, Sodium Benzoate, Lactoperoxidase , Mentha Piperita (Peppermint Oil-includes limonene), Potassium Thiocyanate, Menthol, Lactoferrin , Lysozyme, Glucose Oxidase, Calcium Lactate


Questions Or Comments?



Call Tel. : 908-420-3759 weekdays or, email us: [email protected]


Principal Display Panel - 105 G Tube Carton



NDC 69297-000-19

Oral 7®Xylitol
balancing your mouth's natural flora

Beneficial for the
whole family!

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