Label: SODIUM FLUORIDE- sodium fluoride solution/ drops
- NDC Code(s): 51862-165-50
- Packager: Libertas Pharma, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated May 21, 2011
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- SPL UNCLASSIFIED SECTION
* Conforms to new ADA and AAP guidelines for supplementation.
DOSAGE SCHEDULE * WATER F CONTENT AGE 0- 0.3 PPM 0.3-0.6 PPM > 0.6 PPM 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
Each mL of Sodium Fluoride Drops 0.5 mg contains 0.5 mg fluoride ion (F-) from 1.1 mg sodium fluoride (NaF). For use as a dental caries preventive in pediatric patients. Sugar-free and saccharin-free.
Active Ingredients: Sodium Fluoride 0.11% (w/v).
Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sucralose, yellow #6.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Close
- CLINICAL PHARMACOLOGY
Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization and by inhibiting the cariogenic microbial process.Close
- INDICATIONS AND 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 provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F.Close
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.Close
- ADVERSE REACTIONS
Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Close
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 dispensed at one time.Close
- 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)*
* Conforms to new ADA and AAP guidelines for supplementation.Close
- HOW SUPPLIED
Sodium Fluoride Drops 0.5 mg is supplied in 50 mL bottles with calibrated dropper,
TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing.
Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984, p.339-402. Jakush, J, New Fluoride schedule adopted. ADA News, May 16, 1994, p.12,14.
Store at controlled room temperature 15˚ to 30˚ C (59˚ to 86˚ F).
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11 165-50 743631
- Container Label
Sodium Fluoride Drops
0.5 mg Drops
SUGAR and SACCHARIN FREE
For Children and Adults
1 2/3 fl. oz. (50 mL)
- INGREDIENTS AND APPEARANCE
sodium fluoride solution/ drops
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-165 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) Product Characteristics Color ORANGE (peach) Score Shape Size Flavor PEACH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51862-165-50 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 Unapproved drug other 05/21/2011 Labeler - Libertas Pharma, Inc. (962128943)