NDC 59779-072 Antiseptic
Eucalyptol, Menthol, Methyl Salicylate, Thymol Mouthwash Oral

Product Information

Antiseptic is a human over the counter drug product labeled by Cvs Pharmacy, Inc. The generic name of Antiseptic is eucalyptol, menthol, methyl salicylate, thymol. The product's dosage form is mouthwash and is administered via oral form.

Product Code59779-072
Proprietary Name 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.
Antiseptic
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Product Type 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.
Human Otc Drug
Dosage FormMouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
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.
Cvs Pharmacy, Inc
Labeler Code59779
FDA Application Number 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.
part356
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-09-1995
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Antiseptic?


Product Packages

NDC 59779-072-09

Package Description: 887 mL in 1 BOTTLE, PLASTIC

NDC 59779-072-12

Package Description: 1500 mL in 1 BOTTLE, PLASTIC

NDC 59779-072-69

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 59779-072-77

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 59779-072-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

Product Details

What are Antiseptic Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • EUCALYPTOL .92 mg/mL - A monoterpene and cyclohexanol derivative that is the major component of EUCALYPTUS OIL. It is used in mouthwash, insect repellent, and as a cough suppressant, and also is widely used as a flavoring agent and solvent. It has antimicrobial properties.
  • MENTHOL .42 mg/mL - A monoterpene cyclohexanol produced from mint oils.
  • METHYL SALICYLATE .6 mg/mL
  • THYMOL .64 mg/mL - A phenol obtained from thyme oil or other volatile oils used as a stabilizer in pharmaceutical preparations, and as an antiseptic (antibacterial or antifungal) agent.

Antiseptic Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1043619 - eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash
  • RxCUI: 1043619 - eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash

Antiseptic Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Antiseptic Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.030%

Thymol 0.064%


Purpose



antigingivituis, antiplaque


Use



   helps control plaque that leads to gingivitis


Warnings



   for this product


Do Not Use



if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.


Stop Use And Ask A Dentist If



gingivitis, bleeding, or redness persists for more than 2 weeks


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



  • do not swallow
  • not inteneded to replace brushing or flossing
  • adults and children 12 years of age and older - vigorously swish 20 ml between teeth for 30 seconds then spit out

    children under 12 years of age - consult a dentist or doctor


Other Information



Store at room temperature (59° -77° F)


Inactive Ingredients



water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine FreshBurst Antiseptic


Adverse Reactions



Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2016 CVS/pharmacy

CVS.com  V-16224

072.002/072AL


Principal Display Panel



CVS

Healh

Compare to the active ingredients in Listerine FreshBurst Antiseptic

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

Kills germs that cause plaque, gingivitis & bad breath

Green Mint

ADA

Accepted

American

Dental

Association

Sealed with printed neckband for your protection. Do not use if broken or missing.

1.5 L (50.7 FL OZ)


* Please review the disclaimer below.