SUPERSMILE- sodium monofluorophosphate paste, dentifrice

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
24-08-2022

Viambatanisho vya kazi:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Inapatikana kutoka:

Robell Research, Inc.

Njia ya uendeshaji:

DENTAL

Dawa ya aina:

OTC DRUG

Matibabu dalili:

Anticavity toothpaste Aids in the prevention of dental cavities.

Idhini hali ya:

OTC monograph final

Tabia za bidhaa

                                SUPERSMILE- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
ROBELL RESEARCH, 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._
----------
EXTRA WHITE - TRIPLE MINT
ACTIVE INGREDIENT:
Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)
PURPOSE:
Anticavity toothpaste
USES:
Aids in the prevention of dental cavities.
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 years of age: Consult a dentist or a doctor.
INACTIVE INGREDIENTS:
Water, Sorbitol, Calprox®, Citric Acid, Dicalcium Phosphate, Sodium
Bicarbonate,
Titanium Dioxide, Calcium Carbonate, Flavor, Cellulose Gum, Sodium
Perborate,
Magnesium Carbonate, Corn Starch, Sodium Lauryl Sulfoacetate, Sodium
Saccharin.
PRINCIPAL DISPLAY PANEL
supersmile®
extra white
triple mint
professional
extra
whitening
toothpaste
contains fluoride
Net wt. 7 oz / 198.5 g
SUPERSMILE
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53567-0738
ROUTE OF ADMINISTRATION
DENTAL, ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION -
UNII:Q80VPU408O)
FLUORIDE ION
1.4 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
Robell Research, Inc.
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SORBITOL (UNII: 506T60A25R)
CALCIUM
                                
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