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

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

AMD Medicom Inc

DCI (Dénomination commune internationale):

sodium fluoride

Composition:

fluoride ion .0272 g in 1 g

Mode d'administration:

DENTAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

AMD Medicom Inc. DentiCare Pro-Foam 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions) Raspberry 4.4 oz / 125 g NDC 64778-0378-1 NPN 80009738 Rx Only in US Item code 10037-RB

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY- 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._
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10037-RB RASPBERRY FOAM
DENTICARE PRO-FOAM 2.72 % TOPICAL SODIUM FLUORIDE
AMD Medicom Inc.
DentiCare Pro-Foam
2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)
Raspberry
4.4 oz / 125 g
NDC 64778-0378-1
NPN 80009738
Rx Only in US
Item code 10037-RB
A topical anti-caries preparation
Directions (for professional use only):
1. Use after thorough prophylaxis
2. To dispense, shake bottle vigorously then invert applicator 180
degrees downward to the bottom of
the tray(s)
Note: fill tray(s) at one quarter full to allow foam to expand
3. Insert tray(s) in mouth and have patient bite down lightly for 1
minute or up to 4 minutes
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the
application
130 applications
Medicinal ingredients:
Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
Water, sucralose, sodium phosphate, xylitol, betaine, pluronic,
raspberry flavor
Warnings: KEEP OUT OF REACH OF CHILDREN
Avoid spraying toward open flame. Store at room temperature. Do not
expose to excessive heat over 40
degrees C or 104 degrees F. Contents under pressure. Do not puncture
and incinerate.
Do not use if seal is broken.
Rx (in US only)
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
DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY
sodium fluoride aerosol, foam
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 4778 -0 378
ROUTE OF ADMINISTRATION
DENTAL
AMD Medicom Inc
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