FLUORBON DROPS- sodium fluoride solution

Fluorbon Drops by

Drug Labeling and Warnings

Fluorbon Drops by is a Prescription medication manufactured, distributed, or labeled by KIRKMAN GROUP, INC., KIRKMAN LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

Perry Fluorabon Drops (0.25 mg Fluoride ion per 0.6 ml) are dye free. Each 0.6 ml contains 0.25 mg of the fluoride ion (F) from 0.55 mg sodium fluoride (NaF). Each 0.6 ml for oral administration contains sodium fluoride equivalent to 0.25 mg of the fluoride ion and the following inactive ingredients:

Purified Water USP, Methylparaben, 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 cariogenic 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. Perry Fluorabon Drops (0.25 mg Fluoride ion per 0.6 ml) were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F).

CONTRAINDICATIONS:

Perry Fluorabon Drops (0.25 mg Fluoride ion per .6 ml), are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months. Do not administer fluoride (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 pm. Read directions carefully before using.

PRECAUTIONS:

General:

Please refer to CONTRAINDICATIONS,WARNINGS, and OVERDOSAGE sections for overdose concerns.  Use in pediatric patients blow 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 mild and caution should be exercised when Perry Fluorabon Drops (.025 mg Fluoride ion per 0.6 ml) are administered to nursing women.

Pediatric Use:

The use of Perry Fluorabon Drops (0.25 mg Fluoride ion per 0.6 ml) as a caries preventative 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 (with 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.

STORAGE AND HANDLING:

Store at Controlled Room Temperature, 20-25 °C (38-77 °F). See USP “Controlled Room”

NDC: 11763-524-20  

Manufactured by Kirkman Laboratories, Inc.
Kirkman Laboratories Inc.
17387 SW 63 Ave.
Lake Oswego, OR 97035

PRINCIPAL DISPLAY PANEL:

Perry
MEDICAL

FLUORABON DROPS USP

An Aid in the Prevention of Dental Caries

Each 0.6 mL of this solution contains 0.25 mg of Fluoride Ion as supplied by Sodium Fluoride

CAUTION: Rx only

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

2 FL. OZ. (60 mL)
NDC: 11763-524-20

DESCRIPTION:  Each 0.6 mL contains 0.55 mg of Sodium Fluoride, equivalent to 0.25 mg of the fluoride ion.

ACTIONS: Sodium Fluoride becomes incorporated in the apatite structure of teeth, thereby increasing their ability to resist corrosion.

INDICATIONS: As an aid in the prevention of dental caries.

CONTRAINDICATIONS: Fluorabon Drops should not be used where the community water supply contains more than 0.6 ppm of fluoride ion.

WARNINGS: The recommended dosage of sodium fluoride should not be exceeded. Excessive doses may produce mottling of the tooth enamel and bone changes. The dosage of fluoride should be adjusted if the local water supply contains natural or added fluoride.

Daily Dosage (Fluoride Ion)

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	0.6 mL	1.2 mL	2.4 mL
0.3 to 0.6 ppm	0	0	0.6 mL	1.2 mL
Greater than 0.6 pm	Greater then 0.6 ppm Fluoride Supplements Contraindicated

DOSAGE AND ADMINISTRATION:  Do not exceed recommended dosage. Dispense directly into mouth or in food that will be totally consumed.

Refer to label for additional information.

Keep Out of the Reach of Children

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

The packaging of this product contains dry natural rubber.
 

Perry
MEDICAL

FLUORABON DROPS USP

An Aid in the Prevention of Dental Caries

Each 0.6 mL of this solution contains 0.25 mg of Fluoride Ion as supplied by Sodium Fluoride.

CAUTION: Rx only

Mfg. by
KIRKMAN LABORATRIES, INC.
Lake Oswego, OR 97035

2 FL. OZ. (60 mL)
NDC: 11763-524-20

ACTIONS: Sodium Fluoride becomes incorporated in the apatite structure of teeth, thereby increasing their ability to resist corrosion.

INDICATIONS: As an aid in the prevention of dental caries.

CAUTION:  If pregnant or nursing a baby, consult your physician or pharmacist before using tis product.

CONTRAINDICATIONS: Fluorabon Drops should not be used where the community water supply contains more than 0.6 ppm of fluoride ion.

WARNINGS: The recommended dosage of Sodium Fluoride should not be exceeded. Excessive doses may produce mottling of the tooth enamel and bone changes. The dosage of fluoride should be adjusted if the local water supply contains natural or added fluoride.

Daily Dosage (Fluoride Ion)

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	0.6 mL	1.2 mL	2.4 mL
0.3 to 0.6 ppm	0	0	0.6 mL	1.2 mL
Greater than 0.6 pm	Greater than 0.6 ppm Fluoride Supplements Contraindicated

Do not exceed recommended dosage. Dispense directly into mouth or in food that will be totally consumed.

For complete information, see package insert.

Keep Out of the Reach of Children.

FL048.1    See outer carton for ingredients
 

INGREDIENTS AND APPEARANCE

FLUORBON DROPS 
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11763-524
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.55 mg  in 0.6 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: 11763-524-20	1 in 1 CARTON	07/16/1997
1		60 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		07/16/1997

Labeler - KIRKMAN GROUP, INC. (095275447)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN LABORATORIES INC		180802803	manufacture(11763-524)