SUPERSMILE PROFESSIONAL WHITENING- fluoride paste, dentifrice

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

ROBELL RESEARCH, INC.

מסלול נתינה (של תרופות):

DENTAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

Anticavity toothpaste Aids in the prevention of dental cavities.

מצב אישור:

OTC monograph final

מאפייני מוצר

SUPERSMILE PROFESSIONAL WHITENING- FLUORIDE 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._
----------
DRUG FACTS
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,
children under 6 years old.
DIRECTIONS :
For best results: Brush teeth thoroughly after each meal, at least
twice a day, or as directed by a dentist.
DIRECTIONS :
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 Phosphate Dihydrate, Sodium Bicarbonate,
Calcium Carbonate, Titanium
Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Flavor, Corn
Starch, Magnesium Carbonate,
Sodium Lauryl Sulfoacetate, Methyl Paraben, Sodium Saccharin, Propyl
Paraben
QUES TIONS :
1-800 -784 -SMILE
TUBE LABEL
SUPERSMILE PROFESSIONAL WHITENING
fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5356 7-0 10 1
ROUTE OF ADMINISTRATION
DENTAL
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
0 .76 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CALCIUM PERO XIDE (UNII: 7FRO2ENO9 1)
SO DIUM PERBO RATE (UNII: Y52BK1W9 6 C)
SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)
CALCIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: L11K75P9 2J)
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)
MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA)
STARCH, CO RN (UNII: O8 232NY3SJ)
SACCHARIN (UNII: FST46 7XS7D)
METHYLPARABEN (UNII: A