Label: DENTICARE PRO-GEL NEUTRAL SODIUM FLUORIDE- sodium fluoride gel
- NDC Code(s): 64778-0220-1, 64778-0220-3
- 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
A topical anti-caries preparation in a pH 7 thixotropic gel base
In-Office Directions for use:
- Following prophylaxis treatment, fill 1/3 of tray with gel
- Insert tray in the patient's mouth
- Have patient bite down lightly for 4 minutes
- Remove tray(s) and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after the application
Home Care Directions for use:
- Use only on the advice of a dentist
- Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes.
- Expectorate and rinse well. Do not eat or drink for 30 minutes after the application.
Medicinal ingredients: Fluoride ions 0.5% w/w (from 1.1% w/w neutral sodium fluoride)
- Non-Medicinal Ingredients
- Contact Information
- Principal Display Panel
INGREDIENTS AND APPEARANCE
DENTICARE PRO-GEL NEUTRAL SODIUM FLUORIDE
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0220 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.011 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0220-3 12 in 1 CASE 12/01/2017 1 NDC:64778-0220-1 480 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 12/01/2017 Labeler - AMD Medicom Inc. (256880576) Registrant - AMD Medicom Inc. (256880576)