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

XEROSTOM

Bio Cosmetics

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Xerostom Mouthwash

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Sodium Fluoride 0.055%

Purpose Section

Anticavity Rinse

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 rinsing, 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 use at least twice a day after brushing.
Pour 10 mililiters; vigorously swish 10mililiters of rinse between teeth for I minute.
Then spit out.

Inactive Ingredient

Water
Betaine
Glycerin
Peg-40 Hydrogenated Castor Oil
Propylene Glycol
Xylitol
Aroma
Potassium Phosphate
Diazolidinyl Urea
Allantoin
Olive oil
Sodium Methyl paraben
Sodium Propyl Paraben
Chlorophyll
D-Panthenol
Tocopheryl Acetate
Sucralose
Parsley Oil.

Principal Display panel

Principal Display panel

XEROSTOM

SODIUM FLUORIDE MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61041-211
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.559 mg

Inactive Ingredients

Ingredient Name Strength
water
BETAINE
GLYCERIN
POLYOXYL 40 HYDROGENATED CASTOR OIL
propylene glycol
Xylitol
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
DIAZOLIDINYL UREA
ALLANTOIN
olive oil
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
CHLOROPHYLL
DEXPANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
Sucralose
PARSLEY OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 250 in 1 BOTTLE
2 NDC:61041-211-09 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-11-15


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