AMERFRESH- sodium monofluorophosphate paste, dentifrice

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)

Dostępny od:

Amercare Products Inc

INN (International Nazwa):

Sodium Monofluorophosphate

Skład:

Sodium Monofluorophosphate 0.76 g in 100 g

Droga podania:

DENTAL

Typ recepty:

OTC DRUG

Wskazania:

Anticavity helps protect against cavities.

Status autoryzacji:

OTC monograph final

Charakterystyka produktu

AMERFRESH- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
AMERCARE PRODUCTS 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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AMERFRESH
_FLUORIDE TOOTHPASTE_
DRUG FACTS
ACTIVE INGREDIENT
Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)
PURPOS E
Anticavity
US E
helps protect against cavities.
WARNING
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
centre immediately.
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 or a
physician.
Children 2 to 6 years
use only a pea sized amount and supervise child's
brushing and rinsing to minimize swallowing.
Children under 2 years Ask a dentist or physician.
INACTIVE INGREDIENTS
Sorbitol, Silica, Calcium Carbonate, Methyl Paraben Sodium, Propyl
Paraben Sodium, Flavour, Sodium
Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.
EXCLUSIVE DISTRIBUTOR: AMERCARE PRODUCTS INC. SEATTLE. WA 98165-2226.
PRINCIPAL DISPLAY PANEL - 141 G CARTON LABEL
AMERFRESH
_FLUORIDE TOOTHPASTE_
®
®
_NET WT. 5 oz (141g)_
AMERFRESH
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5146 0 -50 0 0
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM MO NO FLUO RO PHO SPHA TE (UNII: C8 10 JCZ56 Q) (Fluo ride Io
n -
UNII:Q8 0 VPU40 8 O)
So dium
Mo no fluo ro pho spha te
0 .76 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CA LCIUM CA RBO NA TE (UNII: H0 G9 379 FGK)
42 g in 10 0 g
WA TER (UNII: 0 59 QF0 KO0 R)
SO RBITO L (UNII: 50 6 T6 0 A25R)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
SO DIUM LA URYL SULFA TE (UNII: 36 8 GB5141J)
CA RBO XYMETHYLCELLULO SE SO DIUM (UNII: K6