SYNEDENT FLX- sodium fluoride mouthwash 
Synedgen Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Synedent FLX 10 oz

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

LabelSample

SYNEDENT FLX 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42368-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 49.882 g  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42368-005-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2017
Labeler - Synedgen Inc. (830276353)

Revised: 3/2020
Document Id: a0202e19-0c01-8208-e053-2a95a90aa1ca
Set id: a0159047-5f4b-6190-e053-2a95a90a6d0e
Version: 2
Effective Time: 20200305
 
Synedgen Inc.