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XEROSTOM by Bio Cosmetics S L

Medically reviewed on October 2, 2017

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 Section

Anticavity 

Keep out of reach of children

Keep out of reach of children 12yrs of age and under

Indications & Usage Section

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children 12 years of age and under.
For external use only. If you accidentally swallow more than used for brushing, get medical help or contact a Poisson Control Center immediately.
Do not use if you are allergic to any of the ingredients.

Dosage and administration

Adults and children over 12 years apply toothpaste onto a soft bristle toothbrush brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good
habits are established.

Inactive Ingredient

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.

Principal Display panel

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:61041-212-011 TUBE in 1 CARTON
164 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/08/2013
Labeler - Bio Cosmetics S L (513423178)
Establishment
NameAddressID/FEIOperations
LABORATORIOS COSMODENT SL513012153manufacture(61041-212)

 
Bio Cosmetics S L

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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