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Generic Name: sodium fluoride
Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Sodium Fluoride

Flura-Drops Description

Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are dye free. Each 4 drop dose of 2.21 mg (full strength) contains 1.0 mg of the fluoride ion (F-) from 2.21 mg sodium fluoride (NaF).

Each 4 drops for oral administration contains sodium fluoride equivalent to 1.0 mg of the fluoride ion and the following inactive ingredients: Purified Water USP, methylparaben and propylparaben.

Flura-Drops - 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 carcinogenic microbial process.

Indications and Usage for Flura-Drops

For once daily, self-administered, systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries. Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.


Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under the age of 6 months.

Do not administer Fluoride Liquid (any strength) to pediatric patients under age 6 months.


Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.

Keep out of the reach of children.



Please refer to CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE sections for overdose concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

Drug Interactions:

Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Nursing Mothers:

It is not known if fluoride ion is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are administered to nursing women.

Pediatric Use:

The use of Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence.

Geriatric Use:

Not indicated for use in geriatric patients.

Adverse Reactions

Allergic rash and other idiosyncrasies have rarely been reported.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for up to 24 hours. If less than 5 mg sodium fluoride/kg body weight (i.e. less than 2.3 mg sodium fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g. milk, 5% calcium gluconate, or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg sodium fluoride/kg of body weight (i.e. more than 6.9 mg sodium fluoride/lb of body weight), induce vomiting and seek emergency medical help.

Flura-Drops Dosage and Administration

Follow the directions for using this medication provided by your doctor. This medicine may be given undiluted or mixed with a non-dairy liquid.

Daily Pediatric Dose
Fluoride Content of
Drinking Water:
Birth to
6 mos.
6 mos. to
Age 3
Age 3
to 6
Age 6
to 16
Less than 0.3 ppm 0 1 drop 2 drops 4 drops
0.3 to 0.6 ppm 0 0 1 drop 2 drops
Greater than 0.6 ppm 0 0 0 0
May be mixed with water or fruit juice; do not mix with milk or dairy products.


Store at Controlled Room Temperature, 20–25 °C (68–77 °F). See USP Controlled Room Temperature.

NDC: 58223-517-24



Four Single Drops (0.2cc) contain: NaF 2.21mg representing 1.0 mg of the Fluoride Ion

CAUTION: U.S. Federal law prohibits dispensing without prescription.

Ingredients: Purified Water USP, Sodium Fluoride USP, Methylparaben, Propylparaben.

Manufactured by
Lake Oswego, OR 97035


NDC 58223-517-24

CAUTION: U.S. Federal Law prohibits dispensing without prescription.

The packaging of this product contains dry natural rubber.


Kirkman Laboratories Inc.
17387 SW 63rd Ave.
Lake Oswego. OR 97035



FOUR SINGLE DROPS (0.2cc) CONTAIN: NaF 2.21 mg. representing 1.0 mg. of the Fluoride Ion

NDC 58223-517-24

CAUTION: U.S. Federal Law prohibits dispensing without prescription

24 cc

The packaging of this product contains: Dry natural rubber. 

Mfg By:
Kirkman Laboratories, Inc.,
Lake Oswego, OR 97035

See outer carton for ingredients.


sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58223-517
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2.21 mg  in .2 mL
Inactive Ingredients
Ingredient Name Strength
# Item Code Package Description
1 NDC:58223-517-24 1 BOTTLE, DROPPER in 1 BOX
1 24 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2014
Labeler - KIRKMAN GROUP, INC. (095275447)
Name Address ID/FEI Operations
Revised: 05/2014