SYNEDENT FLX- sodium fluoride mouthwash

Synedent FLX by

Drug Labeling and Warnings

Synedent FLX by is a Otc medication manufactured, distributed, or labeled by Synedgen Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium fluoride 0.05% (0.02% fluoride ion)

Purpose

Anticavity

Directions

Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. 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.

USE

Aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing.

Warning

Keep out of reach of children

Inactive Ingredients

Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide

Other Information

Store at room temperature

Question?

Call toll-free 855-774-7962

Label Sample

INGREDIENTS AND APPEARANCE

SYNEDENT FLX 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42368-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	49.882 g  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42368-005-01	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2017

Labeler - Synedgen Inc. (830276353)