NDC 0363-9670 Walgreens Cool N Heat Dry

Lidocaine, Menthol

NDC Product Code 0363-9670

NDC 0363-9670-35

Package Description: 113 g in 1 BOTTLE, SPRAY

NDC Product Information

Walgreens Cool N Heat Dry with NDC 0363-9670 is a a human over the counter drug product labeled by Walgreens Co. The generic name of Walgreens Cool N Heat Dry is lidocaine, menthol. The product's dosage form is aerosol, spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1595448.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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 Dry 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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ISOBUTANE (UNII: BXR49TP611)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)

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: Walgreens Co
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: 08-09-2021 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.

Walgreens Cool N Heat Dry Product Label Images

Walgreens Cool N Heat Dry 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

Lidocaine 4%Menthol 1%

​Purposes

Topical anestheticTopical analgesic

​Use

Temporarily relieves minor pain

​Warnings

​For external use onlyDo not use  • on large areas of the body or on cut, irritated or swollen skin• on puncture wounds  • for more than one week without consulting a doctor​When using this product• use only as directed. ​Read and follow all directions and warnings on this label.• do not allow contact with the eyes and mucous membranes• rare cases of serious burns have been reported with products of this type• do not apply to wounds or damaged, broken or irritated skin• avoid spraying on face  • avoid inhalation of spray• do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use• do not use at the same time as other topical analgesics• a transient burning sensation may occur upon application but generally disappears in several days • avoid applying into skin folds​Stop use and ask a doctor if  • condition worsens  • redness is present  • irritation develops• symptoms persist for more than 7 days or clear up and occur again within a few days• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied​Extremely Flammable  • do not use near heat or flame or while smoking• avoid long term storage above 104°F (40°C)  • do not puncture or incinerate. Contents under pressure.• do not store at temperatures above 120°F (49°C)​If pregnant or breast-feeding, ​ask a health professional before use.

Otc - Keep Out Of Reach Of Children

​Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

Adults and children over 12 years:• ​spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period• product will dry quickly on its own, and does not need to be rubbed in​children 12 years or younger:​ ask a doctor

​Inactive Ingredients

Caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30%)

* Please review the disclaimer below.