OPTIRINSE PLUS- remineralizing fluoride rinse liquid

OptiRinse Plus by

Drug Labeling and Warnings

OptiRinse Plus by is a Otc medication manufactured, distributed, or labeled by Laboratoires MSP Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in 10 mL)

Cetylpyridinum Chloride 0.05%

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

Purpose

Antigingivitis/antiplaque

Anticavity

Uses

• Aids in the prevention of dental cavities
• Helps prevent and reduce plaque and gingivitis
• Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

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

WARNINGS

• Ask a dentist if symptoms persist or condition worsens after regular use.

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

• Store at room temperature (15-30°C)
• Do not use if safety seal is broken or missing

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 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

• Anti-cavities
• Anti-gingivitis
• 10% Xylitol
• Alcohol free
• Kills bacteria
• Lightly flavored
• Neutral pH

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.

INGREDIENTS AND APPEARANCE

OPTIRINSE PLUS 
remineralizing fluoride rinse liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77982-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.05 mg  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77982-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/04/2020

Labeler - Laboratoires MSP Inc (251046124)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires MSP Inc		251046124	manufacture(77982-001)