NDC 77982-001 Optirinse Plus

Remineralizing Fluoride Rinse

NDC Product Code 77982-001

NDC 77982-001-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Optirinse Plus with NDC 77982-001 is a a human over the counter drug product labeled by Laboratoires Msp Inc. The generic name of Optirinse Plus is remineralizing fluoride rinse. The product's dosage form is liquid and is administered via dental form.

Labeler Name: Laboratoires Msp Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Optirinse Plus Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CETYLPYRIDINIUM CHLORIDE .05 mg/mL
  • SODIUM FLUORIDE .05 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratoires Msp Inc
Labeler Code: 77982
FDA Application Number: part356 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-04-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Optirinse Plus Product Label Images

Optirinse Plus Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In 10 Ml)

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

Purpose

Antigingivitis/antiplaqueAnticavity

Uses

  • Aids in the prevention of dental cavitiesHelps prevent and reduce plaque and gingivitisHelps 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 olderUse once a day after brushing your teeth with a toothpasteRemove capPour 10 milliliters into a cap (10 mL mark on inside of cap); do not fill above 10 mL markVigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit outDo not swallow the rinseDo not eat or drink for 30 minutes after rinsingInstruct 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 PlusContains Citrox patented formulaNatural Bioflavinoid ComplexIdeal for Adults & children00.05% NAF Remineralizing Fluoride RinseGrape Flavor16.9 fl oz (500 ml)Recommended by Dental ProfessionalsAnti-cavitiesAnti-gingivitis10% XylitolAlcohol freeKills bacteriaLightly flavoredNeutral pHQuestions? 1 888 442.7070 or boutique.oralscience.comDistributed in USA by:TruLife Distribution, 401 E Las Olas Blvd Suite 1400, Fort Lauderdale,Floirida USA 33301 / 954.414.0380X-PUR is a registered trademark of Oral Science Inc.

* Please review the disclaimer below.