Label: DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY- sodium fluoride liquid
- NDC Code(s): 64778-0448-1
- Packager: AR Medicom Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated February 26, 2010
If you are a consumer or patient please visit this version.
2% Neutral Sodium Fluoride Oral Rinse
1.9 L / 64 fl oz
- DOSAGE & ADMINISTRATION
For topical application to aid in the prevention of dental caries. Neutral pH is especially safe for crowns and restorations.
1. Dispense 10mL of Denti-Rinse 2% Neutral Sodium Fluoride solution into a measuring cup.
2. Instruct patient to rinse vigorously for 1 minute with 10mL of the solution around and between teeth, and then expectorate.
3. For maximum benefit, repeat the rinse procedure with an additional 10mL.
4. Instruct patient not to eat, drink or rinse mouth for at least 30 minutes.
5. Denti-Rinse solution may also be applied full strength with a cotton tip applicator to teeth isolated with cotton rolls.
Medicinal ingredients: Sodium fluoride 2.0% w/w
- INACTIVE INGREDIENT
Non-Medicinal ingredients: Citric acid (anhydrous), potassium sorbate, purified water, sorbitol, sucralose, red 33, red 40, fruit punch flavourClose
- WARNINGS AND PRECAUTIONS
Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only.
Not recommended for use by children under 6 years of age. Do not swallow.
Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.
Do not use if seal is broken.
- SPL UNCLASSIFIED SECTION
Made in USA for: A.R. Medicom Inc. Montreal, Canada H8T 3J8
Questions: 1-800-361-2862 or www.medicom.com
Item Code 10044-B
- INGREDIENTS AND APPEARANCE
DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY
sodium fluoride liquid
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0448 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion .02 g in 1 mL Product Characteristics Color pink Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0448-1 1900 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2001 Labeler - AR Medicom Inc (247876295)