DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE GRAPE- sodium fluoride aerosol, foam

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

AMD Medicom Inc.

INN (International ime):

SODIUM FLUORIDE

Sastav:

FLUORIDE ION 0.0272 g in 1 g

Administracija rute:

DENTAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Indications: topical anti-caries preparation Directions: - Following prophylaxis treatment, fill ¼ of tray with foam - To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray - Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes - Remove tray and have patient expectorate excess Advise patient not to eat, drink or rinse for 30 minutes after the treatment Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)

Status autorizacije:

unapproved drug other

Svojstava lijeka

DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE GRAPE- SODIUM
FLUORIDE AEROSOL, FOAM
AMD MEDICOM INC.
_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._
----------
10037-GR GRAPE FOAM
DENTICARE PRO-FOAM 2.72 % TOPICAL SODIUM FLUORIDE
GENERAL INFORMATION
AMD Medicom Inc.
DentiCare Pro-Foam
2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)
Grape
4.4 oz / 125 g
NDC 64778-0375-1
NPN 80009738
Rx Only in US
Item code 10037-GR
INDICATIONS AND DIRECTIONS
Indications: topical anti-caries preparation
Directions:
1. Following prophylaxis treatment, fill ¼ of tray with foam
2. To dispense, shake bottle vigorously then invert applicator 180°
downward to the bottom of the tray
3. Insert tray, have patient bite down lightly for a minimum of 60
seconds, up to 4 minutes
4. Remove tray and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after the
treatment
Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium
fluoride)
NON-MEDICINAL INGREDIENTS
Water, sucralose, sodium phosphate, xylitol, betaine, pluronic, grape
flavor
WARNINGS
KEEP OUT OF REACH OF CHILDREN. For profesional use only
Avoid spraying toward open flame. Store at room temperature. Do not
expose to excessive heat over
40°C or 104°F.
Contents under pressure. Do not puncture or incinerate.
Do not use if seal is broken.
CONTACT INFORMATION
Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
H9P 2Z2
Questions:1-800-361-2862
www.medicom.com
PRINCIPAL DISPLAY PANEL
DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE GRAPE
AMD Medicom Inc.
sodium fluoride aerosol, foam
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 4778 -0 375
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 VPU