FDA Label for Xerostom

View Indications, Usage & Precautions

Xerostom Product Label

The following document was submitted to the FDA by the labeler of this product Bio Cosmetics S L. 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 0.22%


Purpose Section



Anticavity 


Keep Out Of Reach Of Children



Keep out of reach of children 12yrs of age and under


Indications & Usage Section



Aids in the prevention of dental cavities.


Warnings



Keep out of reach of children 12 years of age and under.
For external use only. If you accidentally swallow more than used for brushing, get medical help or contact a Poisson Control Center immediately.
Do not use if you are allergic to any of the ingredients.


Dosage And Administration



Adults and children over 12 years apply toothpaste onto a soft bristle toothbrush brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good
habits are established.


Inactive Ingredient



Glycerin
Water
Hydrated Silica
Xylitol
Betaine
Tetrapotassium Pyrophosphate
Olive Oil
Xanthan Gum
Titanium Dioxide
Potassium Phosphate
Flavor
Diazolidinyl Urea
Papain, Parsley Oil
D-Panthenol
Tocopheryl Acetate.


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