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DentiCare Pro-Foam Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: aerosol, foam
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

The DentiCare Pro-Foam brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

DentiCare Pro-Foam Description

AMD Medicom Inc.

DentiCare Pro-Foam

2 % Neutral Topical Sodium Fluoride Foam (0.9 % fluoride ion)

Mint

4.4 oz / 125 g

NDC 64778-0386-1

NPN 80009615

Item code 10038-M

Indications and Usage for DentiCare Pro-Foam

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 in the patient’s mouth, have patient bite down lightly for 1 minute, up to a maximum of 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 0.9 % w/w (from 2% w/w sodium fluoride)


Non-Medicinal Ingredients

Non-Medicinal ingredients:

purified water, sucralose, xylitol, cocamidopropyl betaine, pluronic F-127, mint flavour

Warnings and Precautions

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

Rx Only in US


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

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NEUTRAL TOPICAL
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0386
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g in 1 g
Product Characteristics
Color Score
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0386-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/01/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2004
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Medical Disclaimer