DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel

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 0.0272 g in 1 mL

Mode d'administration:

DENTAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Indications: Topical anti-carie preparation Directions: - Following prophylaxis treatment, fill 1/3 of tray with gel - Insert tray in the patient’s mouth - Have patient bite down lightly for 60 seconds - Remove tray and have patient expectorate excess. Advise patient not to eat, drink or rinse for 30 minutes after application Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- 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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10021-BG BUBBLE GUM GEL
DENTICARE PRO-GEL 2.72 % TOPICAL SODIUM FLUORIDE GEL 60 SEC
APPLICATION
GENERAL INFORMATION
AMD Medicom Inc.
DentiCare Pro-Gel
2.72% Topical Sodium Fluoride Gel
60 Second Application (1.23 % fluoride ions)
Bubble Gum
16.23 fl oz / 480mL
NDC 64778-0213-1
NPN 80008336
RX only in US
Item code 10021-BG
INDICATIONS AND DIRECTIONS
Indications: Topical anti-carie preparation
Directions:
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 60 seconds
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 1.23% w/w (from 2.72% w/w sodium
fluoride)
NON-MEDICINAL INGREDIENTS
Carboxy methyl cellulose sodium, phosphoric acid, water, saccharin
sodium, titanium dioxide, red dye,
bubble gum flavor
WARNINGS
KEEP OUT OF REACH OF CHILDREN. For professional use only. Not
recommended for children
under 18 months of age
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, Quebec, Canada
H9P 2Z2
Questions: 1-800-361-2862
www.medicom.com
PRINCIPAL DISPLAY PANEL
DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 4778 -0 213
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 O)
FLUORIDE ION
0 .0 272 g in 1 mL
PRODUCT CHARACTERISTICS
COLOR