Label: DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE- sodium fluoride liquid
- NDC Code(s): 64778-0446-1, 64778-0446-3
- Packager: AMD Medicom
- 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
- Non-Medicinal Ingredients
- Contact Information
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INGREDIENTS AND APPEARANCE
DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE
sodium fluoride liquid
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0446 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 green Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0446-3 12 in 1 CASE 12/01/2017 1 NDC:64778-0446-1 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 03/01/2001 Labeler - AMD Medicom (256880576) Registrant - AMD Medicom (256880576)