SUPERSMILE- sodium monofluorophosphate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Robell Research, Inc.

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity toothpaste Aids in the prevention of dental cavities.

Authorization status:

OTC monograph final

Summary of Product characteristics

                                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._
----------
SUPERSMILE - MANDARIN MINT
_ACTIVE INGREDIENT:_
Sodium Monoflurophosphate (0.14% w/v Fluoride Ion)
_PURPOSE:_
Anticavity toothpaste
_USES:_
Aids in the prevention of dental cavities.
_WARNINGS:_
As with all fluoride toothpastes, KEEP OUT OF REACH OF CHILDREN UNDER
6 YEARS OLD. If you accidentally
swallow more than used for brushing, get medical help or call a Poison
Control Center right away.
_DIRECTIONS:_
For best results: Brush teeth thoroughly after each meal, at least
twice a day, or as directed by a dentist.
Instruct children under six about good brushing and rinsing habits to
minimize swallowing. Supervise
children as necessary until capable of using without supervision.
Under two years of age consult a
dentist or a doctor before use.
_INACTIVE INGREDIENTS:_
Water, Sorbitol, Dicalcium Phoshate Dihydrate, Sodium Bicarbonate,
Calcium Carbonate, Titanium
Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Flavor, Corn
Starch, Magnesium Carbonate,
Sodium Lauryl Sulfoacetate, Sodium Saccharin
PRINCIPAL DISPLAY PANEL
supersmile®
with the whitening power of Calprox®
MANDARIN MINT
professional
whitening
toothpaste
Contains fluoride.
4.2 oz / 119 g
SUPERSMILE
sodium monofluorophosphate paste, dentifrice
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5356 7-0 9 72
ROUTE OF ADMINISTRATION
DENTAL, ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRE NG TH
STRE NG TH
SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -
UNII:Q8 0 VPU40 8 O)
FLUORIDE ION
1.4 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO RBITO L (UNII: 50 6 T6 0 A25R)
DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TS
                                
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