NDC 77982-001 Optirinse Plus

  1. Labeler Index
  2. Laboratoires Msp Inc
  3. NDC: 77982-001 Optirinse Plus

NDC Product Code 77982-001

NDC CODE: 77982-001

Proprietary Name: Optirinse Plus What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as antigingivitis/antiplaqueanticavity

NDC Code Structure

NDC 77982-001-01

Package Description: 500 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Optirinse Plus with NDC 77982-001 is product labeled by Laboratoires Msp Inc. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)

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
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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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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.