FLURA-DROPS- sodium fluoride liquid

FLURA-DROPS by

Drug Labeling and Warnings

FLURA-DROPS by is a Prescription medication manufactured, distributed, or labeled by HTO Nevada Inc., KIRKMAN LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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 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-.

CONTRAINDICATIONS

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.

WARNINGS

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.

PRECAUTIONS

General:

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.

OVERDOSAGE

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.

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

STORAGE

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

NDC: 58223-517-24

PRINCIPAL DISPLAY PANEL

KIRKMAN LABORATORIES, INC.

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

CAUTION: Rx Only

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

Manufactured by
KIRKMAN LABORATORIES, INC.
Lake Oswego, OR 97035

24cc 

NDC: 58223-517-24

The packaging of this product contains dry natural rubber.
 Rx Only

INGREDIENTS AND APPEARANCE

FLURA-DROPS  
sodium fluoride liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58223-517
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	2.21 mg  in .2 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58223-517-24	1 in 1 BOX	05/01/2014
1		24 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2014

Labeler - HTO Nevada Inc. (117115846)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN LABORATORIES INC		180802803	MANUFACTURE(58223-517)