O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR- sodium fluoride paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Project Noah Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-cavity ■ Helps protect against cavities, plaque, and gingivitis.

Authorization status:

OTC monograph final

Summary of Product characteristics

O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR- SODIUM FLUORIDE PASTE,
DENTIFRICE
PROJECT NOAH INC.
_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._
----------
ACTIVE INGREDIENT
Sodium Fluoride 0.22%(1,000 ppm fluoride ion)
PURPOSE
Anti-cavity
USES
■ Helps protect against cavities, plaque, and gingivitis.
WARNINGS
Please keep out of reach of children under 6 years of age. If more
than used for
brushing is accidentally swallowed, get medical help or contact a
Poison Control Center
right away.
KEEP OUT OF REACH OF CHILDREN
keep out of reach of children under 6 years of age
DIRECTIONS
■ Adults and children 6 years of age and older: Chew tablet briefly
before brushing
teeth thoroughly at least twice a day, after each meal or as directed
by a dentist or
doctor. Instruct children under 12 years of age in good brushing and
rinsing habits (to
minimize swallowing). Children under 6 years of age: Do not use unless
directed by a
dentist or doctor.
OTHER INFORMATION
■ Store at 33.8-86℉(1-30°C)
INACTIVE INGREDIENTS
D-Sorbitol, Xylitol(50,000 ppm), Silicon Dioxide, Sodium Cocoyl
Glutamate,
Microcrystalline Cellulose, Xanthan Gum, Tetrasodium Pyrophosphate,
Sodium
Bicarbonate, Magnesium Stearate, Combined Flavor(Strongmint Flavor),
Combined
Flavor(Coolmint Flavor Powder), Combined Flavor(Spearmint Flavor
Powder),
Hydroxypropylcellulose, Gardenia Yellow, Gardenia Blue, Enzymatically
Modified Stevia,
Bamboo Salt, Yuja Extract, Sage Extract, Pyridoxine Hydrochloride,
L-Menthol
O-BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR (30 TABLETS)
NDC: 82989-010-01
O-BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR (180 TABLETS)
NDC: 82989-010-02
O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR
sodium fluoride paste, dentifrice
Project Noah Inc.
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82989-010
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIE