NDC 62168-0805 Icy Hot Medicated, Advanced Relief

Menthol Patch Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
62168-0805
Proprietary Name:
Icy Hot Medicated, Advanced Relief
Non-Proprietary Name: [1]
Menthol
Substance Name: [2]
Menthol, Unspecified Form
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Lead Chemical Co., Ltd.
    Labeler Code:
    62168
    FDA Application Number: [6]
    505G(a)(3)
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    12-01-2012
    End Marketing Date: [10]
    03-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 62168-0805-4

    Package Description: 300 POUCH in 1 BOX / 5 PATCH in 1 POUCH

    Product Details

    What is NDC 62168-0805?

    The NDC code 62168-0805 is assigned by the FDA to the product Icy Hot Medicated, Advanced Relief which is a human over the counter drug product labeled by Lead Chemical Co., Ltd.. The generic name of Icy Hot Medicated, Advanced Relief is menthol. The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 62168-0805-4 300 pouch in 1 box / 5 patch in 1 pouch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Icy Hot Medicated, Advanced Relief?

    Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patchesadults and children over 12 years:•remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle•carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area•once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area•wear one Icy Hot Patch for up to 8 hours•repeat as necessary, but no more than 3 times dailychildren 12 years or younger: ask a doctorIcy Hot Advanced Relief Patchesadults and children over 12 years:•gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.•remove remaining film backing from both sides and finish applying to skin•use 1 patch for up to 12 hours, once a daychildren 12 years or younger: ask a doctor

    What are Icy Hot Medicated, Advanced Relief Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Icy Hot Medicated, Advanced Relief UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
    • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Active Moiety)

    Which are Icy Hot Medicated, Advanced Relief Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Icy Hot Medicated, Advanced Relief?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [10] What is the End Marketing Date? - 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.

    [12] 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".