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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AMD Medicom Inc

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 0.0272 g in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)

Authorization status:

unapproved drug other

Summary of Product characteristics

DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE STRAWBERRY- 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-ST STRAWBERRY 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)
Strawberry
4.4 oz / 125 g
NDC 64778-0379-1
NPN 80009738
Rx Only in US
Item code 10037-ST
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,
strawberry flavor
WARNINGS
KEEP OUT OF REACH OF CHILDREN. For professional 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
STRAWBERRY
sodium fluoride aerosol, foam
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:64778-0379
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O