XEROSTOM- sodium fluoride paste

XEROSTOM by

Drug Labeling and Warnings

XEROSTOM by is a Otc medication manufactured, distributed, or labeled by Bio Cosmetics S L, LABORATORIOS COSMODENT SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.22%

Purpose

Anticavity 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Indications & Uses aids in the prevention of dental cavities

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. 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 year of age: Consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive Ingredients 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.

QUESTIONS

Questions? info@biocosmetics.es

USA / Canada Toll free: 1-855-688-5385 weekdays from 6.00 a.m to 2.00 p.m.

STORAGE AND HANDLING

Other information store below 25°C (77°F)

Packaging

INGREDIENTS AND APPEARANCE

XEROSTOM 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61041-212
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
BETAINE (UNII: 3SCV180C9W)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
OLIVE OIL (UNII: 6UYK2W1W1E)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PAPAIN (UNII: A236A06Y32)
PARSLEY OIL (UNII: IXK9N7RJ7J)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61041-212-03	6.5 g in 1 PACKET; Type 0: Not a Combination Product	02/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/06/2015

Labeler - Bio Cosmetics S L (513423178)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS COSMODENT SL		513012153	manufacture(61041-212)