X-PUR OPTI-RINSE PLUS- anticavity fluoride rinse mouthwash 
Laboratoires MSP 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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Laboratoires MSP- Oral Science-Mouthwash

Active Ingredient(s)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)............Anticavity

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Warnings

Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

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

Directions

Use once a day after brushing your teeth with a toothpaste
Remove cap
Pour 10 milliliters into a cap (10 mL mark on the inside of cap); do not fill above 10 mL mark Vigorously swish 10 milliliters 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 brushing and rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervision

Consult a dentist or doctor

Inactive ingredients

water, xylitol, glycerin, poloxamer 407, grape flavor, sodium phosphate, bioflavonoids, benzoic acid, cetylpyridinium chloride, mint flavor, red 40

store at room temperature (59-86°F) do not use if safety seal is broken or if it is missing

Package Label - Principal Display Panel

500 mL NDC: 77982-112-11500 mL NDC: 77982-112-11

X-PUR OPTI-RINSE PLUS 
anticavity fluoride rinse mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77982-112
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
XYLITOL (UNII: VCQ006KQ1E)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
GRAPE (UNII: 6X543N684K)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
MINT (UNII: FV98Z8GITP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77982-112-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/04/2021
Labeler - Laboratoires MSP Inc (251046124)

Revised: 10/2022
Document Id: ec2ee3f9-f75b-6d5d-e053-2995a90a7d58
Set id: ba84c007-b4ae-02fa-e053-2995a90a5b67
Version: 3
Effective Time: 20221029
 
Laboratoires MSP Inc