Antiseptic Lil Drug Store Products

Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, And Thymol


Lil' Drug Store Products, Inc
Human Otc Drug
NDC 66715-6861
Antiseptic Lil Drug Store Products also known as Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, And Thymol is a human otc drug labeled by 'Lil' Drug Store Products, Inc'. National Drug Code (NDC) number for Antiseptic Lil Drug Store Products is 66715-6861. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Antiseptic Lil Drug Store Products drug includes Eucalyptol - .92 mg/mL Menthol, Unspecified Form - .42 mg/mL Methyl Salicylate - .6 mg/mL Thymol - .64 mg/mL . The currest status of Antiseptic Lil Drug Store Products drug is Active.

Drug Information:

Drug NDC: 66715-6861
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Antiseptic Lil Drug Store Products
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Antiseptic
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Lil Drug Store Products
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, And Thymol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Lil' Drug Store Products, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:EUCALYPTOL - .92 mg/mL
MENTHOL, UNSPECIFIED FORM - .42 mg/mL
METHYL SALICYLATE - .6 mg/mL
THYMOL - .64 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 01 Dec, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 25 Dec, 2025
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.
Application Number: part356
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Lil' Drug Store Products, Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1043619
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:RV6J6604TK
L7T10EIP3A
LAV5U5022Y
3J50XA376E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
66715-6861-4250 mL in 1 BOTTLE (66715-6861-4)29 Jul, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Active ingredients purpose eucalyptol 0.092%, menthol 0.042% antigingivitis, antiplaque methyl salicylate 0.060%, thymol 0.064% antigingivitis, antiplaque

Product Elements:

Antiseptic lil drug store products eucalyptol, menthol, unspecified form, methyl salicylate, and thymol water alcohol sorbitol poloxamer 407 benzoic acid saccharin sodium sodium benzoate fd&c green no. 3 eucalyptol eucalyptol menthol, unspecified form menthol, unspecified form methyl salicylate salicylic acid thymol thymol

Indications and Usage:

Use helps reduce plaque that leads to gingivitis bleeding gums

Warnings:

Warnings stop use and see your dentist immediately if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth. these may be signs or symptoms of periodontitis, a serious form of gum disease. 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 and Administration:

Directions adults and children 12 years of age and older vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. do not swallow the rinse. children 6 to 12 years of age supervise use children under 6 years of age do not use

Stop Use:

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

Package Label Principal Display Panel:

Principal display panel - 251 ml bottle label quality ⋆ guaranteed ⋆ compare to the active ingredients in listerine ® cool mint ® * blue mint antiseptic mouthwash antigingivitis/antiplaque helps remove germs that cause • bad breath • plaque • gingivitis 8.5 fl oz (251 ml) lil' drug store ® principal display panel - 251 ml bottle label


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.