NDC 63868-214 Antispetic

Eucalyptol, Menthol, Methyl Salicylate, Thymol

NDC Product Code 63868-214

NDC 63868-214-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Antispetic with NDC 63868-214 is a a human over the counter drug product labeled by Chain Drug Manufacturing Assn. The generic name of Antispetic is eucalyptol, menthol, methyl salicylate, thymol. The product's dosage form is mouthwash and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1043619.

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.

Antispetic 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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBITOL (UNII: 506T60A25R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

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: Chain Drug Manufacturing Assn
Labeler Code: 63868
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: 12-28-2010 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.

Antispetic Product Label Images

Antispetic 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

Eucalyptol 0.092%Menthol 0.042%Methyl salicylate 0.060%Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

Help control plaque that leads to gingivitis

Warnings

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

  • 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 swallowchildren under 12 years of age - consult a dentist or doctorthis rinse is not intended to replace brushing or flossing

Other Information

Cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive Ingredients

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

Disclaimer

This product is not manufatured or distriubted by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Adverse Reactions

Distributed by C.D.M.A., Inc43157 W 9 Mile RdNovi, MI 48375www.qualitychoice.comQuestions: 800-93-2362

* Please review the disclaimer below.