FDA Label for Denti-care Denti-foam Topical Sodium Fluoride Bubble Gum
View Indications, Usage & Precautions
Denti-care Denti-foam Topical Sodium Fluoride Bubble Gum Product Label
The following document was submitted to the FDA by the labeler of this product Amd Medicom Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
General Information
AMD Medicom
DentiCare Pro-Foam
2.72 % Topical Sodium Fluoride Foam (1.23 % Fluoride Ions)
Bubble Gum
4.4 oz / 125 g
NDC 64778-0373-1
NPN 80009738
Rx Only in US
Item code 10037-BG
Indications And Directions
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)
Non-Medicinal Ingredients
purified water, sucralose, sodium phosphate monobasic, xylitol, cocamidopropyl betaine, poloxamer 407, bubblegum flavour
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 and 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
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