Optirinse Plus
FDA Label NDC 77982-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Msp Inc for the product Optirinse Plus (NDC 77982-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in 10 ml), purpose, uses, warnings, directions, other information, inactive ingredients, optirinse plus - grape - 500 ml - ndc 77982-001-01, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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-500ml (Optirinse)

Optirinse-500ml (Optirinse)

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.

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