XEROSTOM- sodium fluoride paste 
Bio Cosmetics S L

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.

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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

toothpastelbl

XEROSTOM 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61041-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61041-212-036.5 g in 1 PACKET; Type 0: Not a Combination Product02/06/201504/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/06/201504/30/2025
Labeler - Bio Cosmetics S L (513423178)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS COSMODENT SL513012153manufacture(61041-212)

Revised: 8/2023
Document Id: cda81f4b-2173-4591-815e-d9e24828edb0
Set id: 8048f47c-8bec-411e-b00d-879efe3c806d
Version: 4
Effective Time: 20230825
 
Bio Cosmetics S L