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 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

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: 61041-212-01	1 in 1 CARTON	11/08/2013
1		64 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/08/2013

Labeler - Bio Cosmetics S L (513423178)

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