FLUORIDEX- stannous fluoride rinse liquid

Fluoridex by

Drug Labeling and Warnings

Fluoridex by is a Otc medication manufactured, distributed, or labeled by DEN-MAT HOLDINGS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Stannous Fluoride 0.63% Rinse Concentrate

Purpose

Anticavity

Use

• Aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

WARNINGS

Do not swallow the rinse

Directions

Adults and children 6 years of age and older:

• Do not use before mixing with water
• Use once a day after brushing your teeth with a toothpaste
• Separate provided graduated cup from the mixing cap
• Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate
• Add warm water to 1 oz. fill line
• Place the mixing cap onto the filled cap until it snaps closed
• Shake thoroughly then remove mixing cap
• Use immediately after preparing the rinse
• Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out
• Do not swallow the rinse
• Repeat the procedure with the remaining half of the prepared solution
• Do not eat or drink for 30 minutes after rinising
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• Supervise children as necessary until capable of using without supervision

Children under 6 years of age

• Consult a dentist or doctor

Other Information

• This product may produce surface staining of the teeth
• Adequatetoothbrushing may prevent these stains which are harmful or permanent and may be removed by your dentist
• Store at controlled room temperature 15º - 30ºC (59º - 86º F)
• See package insert for additional information
• For your protection, do not use if tamper seal on box is broken or missing

Inactive Ingredients

Glycerin, Hydrogenated Starch Hydrolysate, Flavor

Questions or comments?

Call: 1-800-752-2564

PRINCIPAL DISPLAY PANEL

NDC: 59883-004-01

FLUORIDEX

DAILY

RENEWAL

Prescription-Strength

Dental Decay Prevention

Oral Rinse Concentrate

CLEAN MINT

0.63% Stannous Fluoride

8.4 fl. oz. (248 ml) Rx Only

INGREDIENTS AND APPEARANCE

FLUORIDEX 
stannous fluoride rinse liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-004-01	1 in 1 BOX	01/11/2016
1		310 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/11/2016

Labeler - DEN-MAT HOLDINGS, LLC (809857704)