NDC 0363-9901 Walgreens Cool N Heat

Menthol, Methyl Salicylate

NDC Product Code 0363-9901

NDC Code: 0363-9901

Proprietary Name: Walgreens Cool N Heat 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.

Non-Proprietary Name: Menthol, Methyl Salicylate 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.


Code Structure
  • 0363 - Walgreen Company
    • 0363-9901 - Walgreens Cool N Heat

NDC 0363-9901-01

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Walgreens Cool N Heat with NDC 0363-9901 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Cool N Heat is menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Walgreen Company

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.


Walgreens Cool N Heat 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.

  • MENTHOL, UNSPECIFIED FORM 100 mg/g
  • METHYL SALICYLATE 300 mg/g

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.

  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOCETETH-20 (UNII: O020065R7Z)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Walgreen Company
Labeler Code: 0363
FDA Application Number: part348 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: 03-15-2019 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: 12-31-2019 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.

Walgreens Cool N Heat Product Label Images

Walgreens Cool N Heat 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 Ingredient

Menthol 10%Methyl salicylate 30%

Purpose

Menthol - Topical analgesicMethyl salicylate - Topical analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints due to •simple backache •arthritis •muscle strains •muscle sprains •bruises

Warnings

For external use only

When Using This Product

  • •use only as directed •do not get into eyes or on mucous membranes •do not apply to wounds or to irritated or damaged skin •do not bandage tightly •do not use with a heating pad or apply external heat

Stop Use And Ask A Doctor If

  • •skin redness or excessive irritation of the skin occurs •condition worsens •symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • •adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily •children under 12 years: ask a doctor

Inactive Ingredients

Glyceryl stearate, isoceteth-20, poloxamer 407, purified water, sodium lauryl sulfate, sorbitan monostearate

* Please review the disclaimer below.

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