XEROSTOM- sodium fluoride mouthwash

XEROSTOM by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.055%

Purpose

Anticavity Rinse

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Indications and Uses aids in the prevention of dental cavities

Warnings

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

Directions

Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingredients 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.

STORAGE AND HANDLING

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

QUESTIONS

Questions? info@biocosmetics.es

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

Packaging

INGREDIENTS AND APPEARANCE

XEROSTOM 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61041-211
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.559 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BETAINE (UNII: 3SCV180C9W)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ALLANTOIN (UNII: 344S277G0Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
CHLOROPHYLL (UNII: 00WNZ48OR9)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PARSLEY OIL (UNII: IXK9N7RJ7J)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61041-211-31	15 mL 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 (513423178)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS COSMODENT SL		513012153	manufacture(61041-211)