NEUTRAL SODIUM FLUORIDE- sodium fluoride gel

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

AMD Medicom Inc.

Via di somministrazione:

DENTAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Indications: Topical anti-carie preparation in a pH 7 thixotropic gel base. Directions: - Following prophylaxis treatment, fll 1/3 of tray with gel - Insert tray in the patient’s mouth - Have patient bite down lightly for 4 minutes - Remove tray and have patient expectorate excess Advise patient not to eat, drink or rinse for 30 minutes after application Medicinal ingredients: Fluoride ions 0.9% w/w (from 2% w/w neutral sodium Fluoride)

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

NEUTRAL SODIUM FLUORIDE- SODIUM FLUORIDE GEL
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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10023-ST STRAWBERRY GEL
DENTICARE PRO-GEL 2% NEUTRAL SODIUM FLUORIDE GEL FOR TOPICAL FLUORIDE
APPLICATION (0.9%
FLUORIDE IONS)
GENERAL INFORMATION
AMD Medicom Inc.
DentiCare Pro-Gel
2% Neutral Sodium Fluoride Gel
Topical Fluoride Applications (0.9% Fluoride Ions)
Strawberry
16.23 fl oz / 480 mL
NDC 64778-0239-1
NPN 80008850
Rx Only for US
Item Code 10023-ST
INDICATIONS AND DIRECTIONS
Indications: Topical anti-carie preparation in a pH 7 thixotropic gel
base.
Directions:
1. Following prophylaxis treatment, fll 1/3 of tray with gel
2. Insert tray in the patient’s mouth
3. Have patient bite down lightly for 4 minutes
4. Remove tray and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after
application
Medicinal ingredients: Fluoride ions 0.9% w/w (from 2% w/w neutral
sodium Fluoride)
NON-MEDICINAL INGREDIENTS
Water, saccharin sodium, hydroxyethyl cellulose, phosphoric acid, red
dye, Strawberry flavor, sodium
hydroxide
WARNINGS
KEEP OUT OF REACH OF CHILDREN. For professional use only.
Store at room temperature. Do not expose to excessive heat over 40ºC
or 104ºF.
Do not use if seal is broken.
CONTACT INFORMATION
Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebe, Canada
H9P 2Z2
Questions: 1-800-361-2862
www.medicom.com
PRINICIPAL DISPLAY PANEL
NEUTRAL SODIUM FLUORIDE
sodium fluoride gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 4778 -0 239
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
AMD Medicom Inc.
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 .0 2 g in 1 mL
PRODUCT CHARACTERISTICS
COLOR
re d
S CORE
S HAP E
S IZ E
FLAVOR
STRAWBERRY