XEROSTOM description, usages, side effects, indications, overdosage, supplying and lots more!

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XEROSTOM

Bio Cosmetics S L

Xerostom Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Principal Display panel

XEROSTOM

XEROSTOM

SODIUM FLUORIDE paste

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61041-212
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.2 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
HYDRATED SILICA
Xylitol
BETAINE
POTASSIUM PYROPHOSPHATE
olive oil
XANTHAN GUM
titanium dioxide
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
DIAZOLIDINYL UREA
Papain
PARSLEY OIL
DEXPANTHENOL
.ALPHA.-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 64 in 1 TUBE
2 NDC:61041-212-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-11-08


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