GO SMILE REFRESH- sodium monofluorophosphate paste, dentifrice

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)

Dostupno od:

Go Smile, Inc.

Administracija rute:

ORAL

Tip recepta:

OTC DRUG

Terapijske indikacije:

ANTICAVITY AIDS IN THE PREVENTION OF DENTAL CAVITIES.

Status autorizacije:

OTC monograph final

Svojstava lijeka

GO SMILE REFRESH- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
GO SMILE, 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._
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ACTIVE INGREDIENTS
SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)
PURPOSE
ANTICAVITY
USES
AIDS IN THE PREVENTION OF DENTAL CAVITIES.
WARNINGS
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.
DIRECTIONS
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY
FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS
DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART
OF
AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL
CHECK-UPS.
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 TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.
INACTIVE INGREDIENTS
SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL
SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN,
SODIUM BENZOATE.
OTHER INFORMATION
STORE AT ROOM TEMPERATURE.
IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL
HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
GO SMILE REFRESH
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:448 73-0 0 6
ROUTE OF ADMINISTRATION
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 -
FLUORIDE ION
.76 g
Go Smile, Inc.
UNII:Q8 0 VPU40 8 O)
FLUORIDE ION
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0 A25R)
WATER (UNII: 0 59 QF0 KO0 R)
HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )
GLYCERIN (UNII: PDC6 A3C0 OX)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
CARBO XYMETHYLCELLULO SE (UNII: 0 5JZI7B1