EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD- sodium fluoride paste, dentifrice

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Dostopno od:

EMAG AG

INN (mednarodno ime):

SODIUM FLUORIDE

Sestava:

FLUORIDE ION 0.16 g in 100 g

Pot uporabe:

DENTAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

Anticavity Aids in the prevention of dental cavities.

Status dovoljenje:

OTC monograph final

Lastnosti izdelka

EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD- SODIUM FLUORIDE PASTE,
DENTIFRICE
EMAG AG
_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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EMMI DENT SODIUM FLUORIDE ANTICAVITY TOOTHPASTE
EMMI DENT SODIUM FLUORIDE ANTICAVITY TOOTHPASTE MILD
ACTIVE INGREDIENT
Sodium fluoride 0.243% (0.16 w/v fluoride ion)
PURPOS E
Anticavity
US E
Aids in the prevention of dental cavities.
WARNINGS
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. If more than used
for brushing is accidentally
swallowed, get medical help or contact a Poison Control Center right
away.
DIRECTIONS
Adults and children 2 years and older: Brush teeth thoroughly,
preferably after each meal or at least
twice a day, or as directed by a dentist or doctor.
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 2 years: Consult a dentist or doctor.
INACTIVE INGREDIENTS
water, hydrated silica, sorbitol, propylene glycol, tetrapotassium
pyrophosphate, xanthan, gum, sodium
C14-16 olefin sulfonate, flavor, titanium dioxide, sodium
methylparaben, sodium saccharin, allantoin,
limonene, chamomile (chamomilla recutita) flower extract, three-lobe
sage (salvia triloba) leaf extract,
citral
REPRESENTATIVE LABELING
EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 39 56 -0 0 1
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
0 .16 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )
EMAG AG
SO RBITO L (UNII: 50 6 T6 0 A25R)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q1