Label: DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY- sodium fluoride liquid
- NDC Code(s): 64778-0448-1, 64778-0448-3
- Packager: AMD Medicom Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated January 27, 2021
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- General Information
Indications and Directions
Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations
Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional 10mL
Advise patient not to eat, drink or rinse for 30 minutes after application
Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls
Medicinal ingredients: Sodium fluoride 2.0% w/w
- Non-Medicinal Ingredients
- Contact Information
- Principal Display Panel
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 0.02 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:64778-0448-3 12 in 1 CASE 12/01/2017 1 NDC:64778-0448-1 1900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2001 Labeler - AMD Medicom Inc. (256880576) Registrant - AMD Medicom Inc. (256880576)