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 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

image description

XEROSTOM
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61041-212
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	LEMON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61041-212-01	1 in 1 CARTON	11/08/2013	04/30/2025
1		64 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	11/08/2013	04/30/2025

Labeler - Bio Cosmetics S L (513423178)

Name	Address	ID/FEI	Business Operations
Establishment
LABORATORIOS COSMODENT SL		513012153	manufacture(61041-212)