Co Cool

Menthol, Peppermint Oil, Pinus Pumilio Branch/leaf Oil


Lydia Co., Ltd.
Human Otc Drug
NDC 72988-0013
Co Cool also known as Menthol, Peppermint Oil, Pinus Pumilio Branch/leaf Oil is a human otc drug labeled by 'Lydia Co., Ltd.'. National Drug Code (NDC) number for Co Cool is 72988-0013. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Co Cool drug includes Menthol - .06 g/100g Peppermint Oil - .01 g/100g Pine Needle Oil (pinus Mugo) - .01 g/100g . The currest status of Co Cool drug is Active.

Drug Information:

Drug NDC: 72988-0013
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: Co Cool
Also known as the trade name. It is the name of the product chosen by the labeler.
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: Menthol, Peppermint Oil, Pinus Pumilio Branch/leaf Oil
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Lydia Co., Ltd.
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:MENTHOL - .06 g/100g
PEPPERMINT OIL - .01 g/100g
PINE NEEDLE OIL (PINUS MUGO) - .01 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:NASAL
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: UNAPPROVED DRUG OTHER
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: 22 Aug, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 14 Jun, 2026
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.
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:Lydia Co., Ltd.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:L7T10EIP3A
AV092KU4JH
6KF1RLN1CI
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.
Pharmacologic Class:Allergens [CS]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Food Additives [CS]
Increased Histamine Release [PE]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
72988-0013-18 g in 1 BOTTLE (72988-0013-1)22 Aug, 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:

Co cool is an essence oil that is the main ingredient of the herb extract of nature. if you put it in your nose when you feel stuffy, your nose feels cool and your head clear.

Product Elements:

Co cool menthol, peppermint oil, pinus pumilio branch/leaf oil water menthol menthol peppermint oil peppermint pine needle oil (pinus mugo) pine needle oil (pinus mugo)

Indications and Usage:

Apply it on the inside of the nose and under the nose as often as necessary, and gently rub the nose.

Warnings:

■ don’t use on the part where there is injury, eczema, or dermatitis ■ if swallowed, get medical help or contact a person control center immediately

Dosage and Administration:

For nasal use only

Package Label Principal Display Panel:

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.