NDC 81359-114 X-pur Opti-rinse Plus

Anticavity Fluoride Rinse

NDC Product Code 81359-114

NDC 81359-114-11

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

X-pur Opti-rinse Plus with NDC 81359-114 is a a human over the counter drug product labeled by Oral Science Inc. The generic name of X-pur Opti-rinse Plus is anticavity fluoride rinse. The product's dosage form is mouthwash and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 240698.

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

X-pur Opti-rinse 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.


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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • MINT (UNII: FV98Z8GITP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)

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: Oral Science Inc
Labeler Code: 81359
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-18-2021 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: 12-31-2022 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.

X-pur Opti-rinse Plus Product Label Images

X-pur Opti-rinse 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 Ingredient(S)

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right awayStop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

Otc - Stop Use

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

Otc - Keep Out Of Reach Of Children

If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Adults and children 6 years 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 the 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 under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
  • Supervise children as necessary until capable of using without supervision
  • Children 6 years and under Consult a dentist or doctor

Inactive Ingredients

Purified water, xylitol, glycerin, poloxamer 407, sodium phosphate, bioflavonoids, benzoic acid, cetylpyridinium chloride, mint flavor, blue 1

Other Safety Information

Store at room temperature (59-86°F) do not use if safety seal is broken or missing

* Please review the disclaimer below.