Denti-Care Denti-Pro Topical Sodium Fluoride
Package insert / prescribing information
Generic name: sodium fluoride
Dosage form: gel
Drug class: Mouth and throat products
Medically reviewed by Drugs.com. Last updated on Nov 21, 2022.
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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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:
- 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)
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 |
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Labeler - AMD Medicom Inc. (256880576) |
Registrant - AMD Medicom Inc. (256880576) |
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