AMERFRESH- sodium fluoride paste

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
03-12-2020

Aktiv ingrediens:

Sodium fluoride-0.22%

Tilgjengelig fra:

SUHAN AEROSOL

Administreringsrute:

DENTAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Anticavity Toothpaste. aids in the prevention of dental cavities

Autorisasjon status:

unapproved drug other

Preparatomtale

                                AMERFRESH- SODIUM FLUORIDE PASTE
SUHAN AEROSOL
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
AMERFRESH FLUORIDE TOOTHPASTE
ACTIVE INGREDIENTS
Sodium fluoride-0.22%
PURPOS E
Anticavity Toothpaste.
US ES
aids in the prevention of dental cavities
WARNINGS
KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE .
If more than used for brushing is accidently swallowed ,get medical
help or contact a Poison
Control Center right away.
DIRECTIONS
Adults and children 6 years of age and older .Brush teeth thoroughly
,preferably after each meal or
at least twice a day,or as directed by a dentist.
Do not swallow.
To minimize the swallowing ,use a pea-sized amount in children under 6
years old.
Supervise children’s brushing until good habits are established.
Children under 2 yrs : ask a dentist before use
INACTIVE INGREDIENTS
Calcium Carbonate, Water,Sorbitol,Hydrated Silica, Sodium Lauryl
Sulphate,Sodium Carboxymethyl
cellulose, Flavor, Sodium Saccharin, Sodium methyl paraben, Sodium
propyl paraben.
PRODUCT LABEL
AMERFRESH
SUHAN AEROSOL
sodium fluoride paste
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:7339 8 -114
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40
8 O)
FLUORIDE ION
2.2 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)
WATER (UNII: 0 59 QF0 KO0 R)
SO RBITO L (UNII: 50 6 T6 0 A25R)
HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED (UNII: K6 79 OBS311)
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
METHYLPARABEN SO DIUM (UNII: CR6 K9 C2NHK)
PRO PYLPARABEN SO DIUM (UNII: 6 25NNB0 G9 N)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7339 8 -114-
                                
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