Sodium Fluoride Drops 0.5 mg/mL Grape Flavored
Product Overview
Brand: Sancilio & Company
Barcode: 3 44946 10328 0
Net Contents: 1.6 Fluid Ounce(s); 50 Milliliter(s)
Serving Size (Overview): 1 mL
Product Type: Mineral [A1299]
Form: Liquid [E0165]
Date Entered: Dec 18, 2021
Market Status: On Market
Suggested Use (Overview): Indications and Usage: As a supplemental source of fluoride. Dosage and Administration: Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F); 6 months to age 3: one half dropperful (1/2 mL); age 3-6: one dropperful (1 mL); age 6-16: two dropperfuls (2mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3: Fluoride supplementation not indicated; age 3-6: one half dropperful (1/2 mL); age 6-16: one dropperful (1mL). Dispense in original container.
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Fluoride | mineral | 0.5 | mg | N/A | Adults and children 4 or more years of age | 1 mL |
Other Ingredients
Water; Glycerin; Xylitol; Propylene Glycol; natural Grape flavor; Sucralose; Methyl Paraben; Propyl Paraben
Label Statements
Branding Statement(s)
- SCIDeveloping Good Science into Great Medicine
Formulation
- (Sodium Fluoride Oral Solution USP) No dyes artificial flavors or sugarSaccharin and gluten free
Precautions
- Dispense under a physician's order Caution: Should be used only when the fluoride content of the drinking water supply is known to be 0.6 parts per million or less. Do not exceed recommended dosage. Keep this product out of the reach of children. If overdosage is suspected seek professional assistance or contact a poison control center immediately 1-800-222-1222. The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.
Statement of Identity
- Dietary Supplement
Other
- Adds a negligible amount of sugar The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA. 44946-1032-8
Suggested Use
- Indications and Usage: As a supplemental source of fluoride. Dosage and Administration: Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F); 6 months to age 3: one half dropperful (1/2 mL); age 3-6: one dropperful (1 mL); age 6-16: two dropperfuls (2mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3: Fluoride supplementation not indicated; age 3-6: one half dropperful (1/2 mL); age 6-16: one dropperful (1mL). Dispense in original container.
Product Specific Information
- Keep tightly closed. Store at controlled room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F).
Seals/Symbols
- Made in the USA
Associated Company Information & Roles
Sancilio & Company Inc.
3874 Fiscal Court,
Riviera Beach,
FL
33404
Roles for this Product:
- Manufacturer