Label: DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE GRAPE- sodium fluoride aerosol, foam
- NDC Code(s): 64778-0375-1, 64778-0375-3
- Packager: AMD Medicom Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Updated December 9, 2020
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- General Information
Indications and Directions
Indications: topical anti-caries preparation
- 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, have patient bite down lightly for a minimum of 60 seconds, up to 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 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-FOAM TOPICAL SODIUM FLUORIDE GRAPE
sodium fluoride aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0375 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 g Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0375-3 12 in 1 CASE 12/01/2017 12/31/2021 1 NDC:64778-0375-1 125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2003 12/31/2021 Labeler - AMD Medicom Inc. (256880576) Registrant - AMD Medicom Inc. (256880576)