Label: DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel
- NDC Code(s): 64778-0219-1, 64778-0219-3
- 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: A topical anti-caries preparation
- 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
- Contact Information
- Principal Display Panel
INGREDIENTS AND APPEARANCE
DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0219 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0272 g in 1 mL Product Characteristics Color pink Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0219-3 12 in 1 CASE 12/01/2017 1 NDC:64778-0219-1 480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2005 Labeler - AMD Medicom Inc. (256880576) Registrant - AMD Medicom Inc. (256880576)