Label: SODIUM FLUORIDE DROPS- sodium fluoride solution/ drops
- NHRIC Code(s): 61269-165-50
- Packager: H2-Pharma, LLC
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated January 24, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
STATEMENT OF IDENTITY
Supplement Facts Serving Size 1.0 mL Servings Per Container 50 Amount Per Serving % Daily Value - *
- Daily Value not established
Fluoride 0.5 mg * *U.S. Recommended Daily Allowance not established. Consult your physician for use by infants and children under 2 years of age.
Active Ingredient: Sodium fluoride 0.11% (w/v).
Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sodium fluoride, sucralose, yellow #6.
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
-
HEALTH CLAIM
DOSAGE SCHEDULE* WATER F CONTENT AGE 0-0.3 PPM 0.3-0.6 PPM > 0.6 PPM - *
- Conforms to new ADA and AAP guidelines for supplementation.
6 months to 3 years 0.25 mg F = 1/2 mL = Half dropperful 0 0 3-6 years 0.5 mg F = 1 mL = One dropperful 0.25 mg F = 1/2 mL = Half dropperful 0 6-16 years 1 mg F = 2 mL = Two dropperfuls 0.5 mg F = 1 mL = One dropperful 0 -
Description
Each 1 mL contains 0.5 mg fluoride ion (F-) from 1.1 mg of sodium fluoride (NaF). For use as a dental caries preventative in pediatric patients. Sugar-free and saccharin-free. Active Ingredient: Sodium fluoride 0.11% (w/v). Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sodium fluoride, sucralose, yellow #6.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- CLINICAL PHARMACOLOGY
-
USAGE
It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries. Sodium Fluoride Drops 0.5 mg were developed to provided systemic fluoride for use as a supplement for patients living in areas where the drinking water fluoride level does not exceed 0.6 ppm F. See guidelines for supplementation from ADA and AAP.
- CONTRAINDICATIONS
-
WARNINGS
See "CONTRAINDICATIONS" above.
-
PRECAUTIONS
See "OVERDOSAGE" section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Not for ophthalmic use.
- ADVERSE REACTIONS
-
OVERDOSAGE
Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. For safety purposes, the total amount of sodium fluoride in a 50 mL bottle of Sodium Fluoride Drops 0.5 mg (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispended at one time.
-
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 (2 mL). 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 (1 mL)1
- 1
- Conforms to new ADA and AAP guidelines for supplementation.
- HOW SUPPLIED
- TAMPER EVIDENT
- *REFERENCES
- RECOMMENDED STORAGE
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
SODIUM FLUORIDE DROPS
sodium fluoride solution/ dropsProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:61269-165 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PEACH (UNII: 3OKE88I3QG) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:61269-165-50 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/04/2017 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color flavor Labeler - H2-Pharma, LLC (028473634)