OPTIRINSE PLUS- remineralizing fluoride rinse liquid 
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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OptiRinse Plus

Active Ingredients (in 10 mL)

Cetylpyridinum Chloride 0.05%

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

Purpose

Antigingivitis/antiplaque

Anticavity

Uses

Warnings

Directions

 Adults and children 6 years of age and older
  • Use once a day after brushing your teeth with a toothpaste
  • Remove cap
  • Pour 10 milliliters into a cap (10 mL mark on 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 12 years under 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

Inactive Ingredients

Purified Water, Xylitol, Glycerin, Grape Flavor, Poloxamer 407, Bioflavonoids, Sodium Phosphate, Benzoic Acid, Mint Flavor, Red 40

OptiRinse Plus - Grape - 500 mL - NDC 77982-001-01

optirinse-500ml

OptiRinse Plus

Contains Citrox patented formula

Natural Bioflavinoid Complex

Ideal for Adults & children

00.05% NAF Remineralizing Fluoride Rinse

Grape Flavor

16.9 fl oz (500 ml)

Recommended by Dental Professionals

Questions? 1 888 442.7070 or boutique.oralscience.com

Distributed in USA by:

TruLife Distribution, 401 E Las Olas Blvd Suite 1400, Fort Lauderdale,

Floirida USA 33301 / 954.414.0380

X-PUR is a registered trademark of Oral Science Inc.

OPTIRINSE PLUS 
remineralizing fluoride rinse liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77982-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 mg  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PULEGONE (UNII: 4LF2673R3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77982-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/04/2020
Labeler - Laboratoires MSP Inc (251046124)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires MSP Inc251046124manufacture(77982-001)

Revised: 11/2020
Document Id: ba492995-a687-43e9-baff-c5f1c3d7b5c2
Set id: 003a6c1e-b03a-41c9-8d0a-a2ee762ac7fe
Version: 2
Effective Time: 20201106
 
Laboratoires MSP Inc