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XEROSTOM by Bio Cosmetics S L

Medically reviewed on April 16, 2018

Dosage form: paste
Ingredients: SODIUM FLUORIDE 2.2mg in 1g
Labeler: Bio Cosmetics S L
NDC Code: 61041-212

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 Toothpaste

Active Ingredient

Sodium Fluoride 0.22%

Purpose

Anticavity 

Keep out of reach of children.

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 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? info@biocosmetics.es

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

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

Packaging

XEROSTOM 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61041-212
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
HYDRATED SILICA 
XYLITOL 
BETAINE 
POTASSIUM PYROPHOSPHATE 
OLIVE OIL 
XANTHAN GUM 
TITANIUM DIOXIDE 
POTASSIUM PHOSPHATE, UNSPECIFIED FORM 
DIAZOLIDINYL UREA 
PAPAIN 
PARSLEY OIL 
DEXPANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61041-212-036.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/06/2015
Labeler - Bio Cosmetics S L (513423178)
Establishment
NameAddressID/FEIOperations
LABORATORIOS COSMODENT SL513012153manufacture(61041-212)

 
Bio Cosmetics S L

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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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