DENTICARE PRO-GEL 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:

A topical anti-caries preparation in a pH 7 thixotropic gel base In-Office Directions for use: - Following prophylaxis treatment, fill 1/3 of tray with gel - Insert tray in the patient's mouth - Have patient bite down lightly for 4 minutes - Remove tray(s) and have patient expectorate excess Advise patient not to eat, drink or rinse for 30 minutes after the application Home Care Directions for use: - Use only on the advice of a dentist - Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes. - Expectorate and rinse well. Do not eat or drink for 30 minutes after the application. Medicinal ingredients: Fluoride ions 0.5% w/w (from 1.1% w/w neutral sodium fluoride)

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

DENTICARE PRO-GEL 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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10022-UN UNFLAVORED GEL
DENTICARE DENTI-PRO 1.1 % NEUTRAL SODIUM FLUORIDE
GENERAL INFORMATION
AMD Medicom Inc.
DentiCare Pro-Gel
1.1% Neutral Sodium Fluoride Gel for Topical Fluoride Applications
(0.5% Fluoride Ions)
Unflavoured / Dye Free
16.23 fl oz / 480mL
NDC 64778-0220-1
NPN 80008841
RX Only in US
Item code 10022-UN
INDICATIONS AND DIRECTIONS
A topical anti-caries preparation in a pH 7 thixotropic gel base
In-Office Directions for use:
1. Following prophylaxis treatment, fill 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(s) and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after the
application
Home Care Directions for use:
1. Use only on the advice of a dentist
2. Apply a thin layer of gel on a toothbrush and brush for up to 4
minutes.
3. Expectorate and rinse well. Do not eat or drink for 30 minutes
after the application.
Medicinal ingredients: Fluoride ions 0.5% w/w (from 1.1% w/w neutral
sodium fluoride)
NON-MEDICINAL INGREDIENTS
Purified water, saccharin sodium, hydroxyethyl cellulose, xylitol,
phosphoric acid, sodium hydroxyde
WARNINGS
KEEP OUT OF REACH OF CHILDREN
Store at room temperature. Do not expose to excessive heat over 40°C
or 104°F
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
DENTICARE PRO-GEL NEUTRAL SODIUM FLUORIDE
sodium fluoride gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 4778 -0 220
ROUTE OF ADMINISTRATION
DENTAL
AMD Medicom Inc.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME