OTC Medication Information: XEROSTOM

XEROSTOM- sodium fluoride mouthwash
Bio Cosmetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Sodium Fluoride 0.055%

Purpose

Anticavity Rinse

Keep out of reach of children.

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 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.

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

Questions? info@biocosmetics.es

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

Packaging

mouthwashlbl
(click image for full-size original)

XEROSTOM
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG 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) FLUORIDE ION 0.559 mg in 1 mL
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
Product Characteristics
Color Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61041-211-31 15 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 02/06/2015 10/31/2024
Labeler — Bio Cosmetics (513423178)
Establishment
Name Address ID/FEI Operations
LABORATORIOS COSMODENT SL 513012153 manufacture (61041-211)

Revised: 08/2023 Bio Cosmetics

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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