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XEROSTOM by Bio Cosmetics

Medically reviewed on April 16, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.559mg in 1mL
Labeler: Bio Cosmetics
NDC Code: 61041-211

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.

Xerostom Mouthwash

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

XEROSTOM 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61041-211
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.559 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61041-211-3115 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/06/2015
Labeler - Bio Cosmetics (513423178)
Establishment
NameAddressID/FEIOperations
LABORATORIOS COSMODENT SL513012153manufacture(61041-211)

 
Bio Cosmetics

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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