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Synedent FLX

Medically reviewed by Drugs.com. Last updated on Mar 5, 2020.

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.02g in 100mL
Labeler: Synedgen Inc.
NDC Code: 42368-005

Synedent FLX 2 oz

Drug Facts

Active Ingredients

Sodium fluoride 0.05% (0.02% fluoride ion)

Purpose Anticavity

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.

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.

Other Information

Store at room temperature.

Inactive Ingredients

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

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Active Ingredients

Sodium fluoride 0.05%

(0.02% w/v fluoride ion)

Keep out of reach of children

Keep out of reach of children

Warnings

If more than indicates is swallowed, get medical attention or contact Poison Control Center right away.

Contains shellfish derivatives.

Not to be used by pets.

Do not use if safety seal is broken or missing.

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.

Inactive Ingredients

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Labels

SYNEDENT FLX 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42368-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER49.882 g  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42368-005-0059.1 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/30/2019
Labeler - Synedgen Inc. (830276353)

 
Synedgen Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.