SUPERSMILE- sodium monofluorophosphate paste, dentifrice

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Fachinformation Fachinformation (SPC)
03-08-2020

Wirkstoff:

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

Verfügbar ab:

Robell Research, Inc.

Verabreichungsweg:

DENTAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Anticavity toothpaste Aids in the prevention of dental cavities.

Berechtigungsstatus:

OTC monograph final

Fachinformation

                                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 ROSEWATER
ACTIVE INGREDIENT:
Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)
PURPOS E:
Anticavity toothpaste
US ES :
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.
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 the 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. For children under two
years of age, consult a dentist or a doctor before use.
INACTIVE INGREDIENTS:
Water, Sorbitol, Dicalcium Phosphate Dihydrate, Calcium Carbonate,
Sodium Bicarbonate, Titanium
Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch,
Flavor, Magnesium Carbonate,
Sodium Lauryl Sulfoacetate, Sodium Saccharin
PRINCIPAL DISPLAY PANEL
Supersmile®
ROSEWATER MINT
professional
whitening
toothpaste
powered by Calprox®
with fluoride.
Net wt. 4.2 oz / 119 g
SUPERSMILE
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5356 7-0 748
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
                                
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