NDC 71927-006 Mouthwash

Menthol, Methyl Salicylate, Thymol

NDC Product Code 71927-006

NDC 71927-006-01

Package Description: 251 mL in 1 BOTTLE

NDC Product Information

Mouthwash with NDC 71927-006 is a a human over the counter drug product labeled by Orazen Inc. The generic name of Mouthwash is menthol, methyl salicylate, thymol. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Orazen 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.


Mouthwash 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.

  • METHYL SALICYLATE .6 mg/mL
  • THYMOL .64 mg/mL
  • EUCALYPTOL .92 mg/mL
  • MENTHOL .42 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN (UNII: FST467XS7D)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Orazen Inc
Labeler Code: 71927
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: 04-22-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Mouthwash Product Label Images

Mouthwash 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

Otc - Active Ingredient

Active ingredients
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Otc - Purpose

Purpose
Antigingivitis, Antiplaque

Indications & Usage

  • Uses
  • Helps reduce plaque that leads to
  • Gingivitisbleeding gums

Warnings

  • Warnings Stop use and see your dentist immediately ifgingivitis, bleeding or redness persists for more than 2 weeksyou have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teethThese may be signs or symptoms of periodontitis, a serious form of gum disease.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age . If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions adult and children 12 years of age and oldervigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.children 6 to 20 years of agesupervise usechildren uner 6 years of agedo not use

Other Safety Information

  • Other informationnot intended to replace brushing or flossingstore at room temperature (59-77F)cold weather may cloud this product, but will not affect its antiseptic properties.

Inactive Ingredient

Inactive ingredients
alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water

* Please review the disclaimer below.

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