NDC 49348-482 Antiseptic
Eucalyptol, Menthol, Methyl Salicylate, Thymol Rinse Oral

Product Information

Antiseptic is a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Antiseptic is eucalyptol, menthol, methyl salicylate, thymol. The product's dosage form is rinse and is administered via oral form.

Product Code49348-482
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 FormRinse - A liquid used to cleanse by flushing.
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.
Strategic Sourcing Services Llc
Labeler Code49348
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.
08-15-1990
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
08-04-2023
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 49348-482-62

Package Description: 1 L in 1 BOTTLE, PLASTIC

NDC 49348-482-89

Package Description: 1.25 L 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 .092 kg/100L - 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 .042 kg/100L - A monoterpene cyclohexanol produced from mint oils.
  • METHYL SALICYLATE .06 kg/100L
  • THYMOL .064 kg/100L - 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.

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

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBITOL (UNII: 506T60A25R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

* 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



Otc - Active Ingredient



Active ingredientsEucalyptol 0.092%, Menthol 0.042%  Methyl salicylate 0.060%, Thymol 0.064%

Otc - Purpose



PurposeAntigingivitis, Antiplaque

Indications & Usage



Use helps control plaque that leads to gingivitis

Warnings



Warnings

Otc - Do Not Use



Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See you dentist immediately.  These may be signs of periodontitis, a serious form of gum disease

Otc - Stop Use



Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

Otc - Keep Out Of Reach Of Children



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.

Dosage & Administration



Directions
adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children under 12 years of age - consult a dentist or doctor

• this rinse is not intended to replace brushing of flossing


Storage And Handling



Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (57⁰-77⁰F)

Inactive Ingredient



Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin,sodium benzoate, FD+C green no. 3

Other



The ADA council on Scientific affairs Acceptance of Sunmak's Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline when used as directed.This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine.

Adverse Reactions



Another Quality ProductDistributed by McKessonOne Post StreetSan Francisco, CA 94104Money Back QuaranteePlease visit us atwww.sunmarkbrand.comDSP-TN-15000DSP-MO-34SDS-TN-15012

Package Label.Principal Display Panel



SUNMARKCompare toListerineActive IngredientsNDC 49348-482-62MOUTHRinseAntisepticADAAcceptedKills germs that causebad breath, plaque + thegum disease gingivitisBLUE MINT33.8 FL OZ ( 1 L)

* Please review the disclaimer below.