NDC 72988-0013 Co Cool

Menthol, Peppermint Oil, Pinus Pumilio Branch/leaf Oil

NDC Product Code 72988-0013

NDC 72988-0013-1

Package Description: 8 g in 1 BOTTLE

NDC Product Information

Co Cool with NDC 72988-0013 is a a human over the counter drug product labeled by Lydia Co., Ltd.. The generic name of Co Cool is menthol, peppermint oil, pinus pumilio branch/leaf oil. The product's dosage form is liquid and is administered via nasal form.

Labeler Name: Lydia Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Co Cool 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.

  • PINE NEEDLE OIL (PINUS MUGO) .01 g/100g
  • MENTHOL .06 g/100g
  • PEPPERMINT OIL .01 g/100g

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lydia Co., Ltd.
Labeler Code: 72988
Marketing Category: UNAPPROVED DRUG OTHER - 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: 08-22-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Co Cool Product Label Images

Co Cool 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

Otc - Active Ingredient

Menthol, Mentha Piperita (Peppermint) Oil, Pinus Pumilio Branch/Leaf Oil

Inactive Ingredient

Water, Glycerin, Alcohol, Menthol, Mentha Piperita (Peppermint) Oil, Pinus Pumilio Branch/Leaf Oil, PEG-60 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Methylparaben, Allantoin, Eucalyptus Globulus Leaf Oil

Otc - 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & 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 & Administration

For nasal use only

* Please review the disclaimer below.