Icy Hot Medicated, Back
Menthol
Lead Chemical Co., Ltd.
Human Otc Drug
NDC 62168-0853Icy Hot Medicated, Back also known as Menthol is a human otc drug labeled by 'Lead Chemical Co., Ltd.'. National Drug Code (NDC) number for Icy Hot Medicated, Back is 62168-0853. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Icy Hot Medicated, Back drug includes Menthol, Unspecified Form - 428.5 mg/1 . The currest status of Icy Hot Medicated, Back drug is Active.
Drug Information:
| Drug NDC: | 62168-0853 |
| 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: | Icy Hot Medicated, Back |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Icy Hot |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Medicated, Back |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lead Chemical Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| 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, UNSPECIFIED FORM - 428.5 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | OTC MONOGRAPH NOT FINAL |
| 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: | 19 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 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. |
| Application Number: | part348 |
| 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. |
| 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: | Lead Chemical Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 420222
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | L7T10EIP3A
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62168-0853-1 | 100 POUCH in 1 CARTON (62168-0853-1) / 5 PATCH in 1 POUCH | 19 May, 2021 | N/A | No |
| 62168-0853-2 | 240 POUCH in 1 CARTON (62168-0853-2) / 1 PATCH in 1 POUCH | 28 Jun, 2021 | N/A | No |
| 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:
Purpose topical analgesic
Product Elements:
Icy hot medicated, back menthol menthol, unspecified form menthol, unspecified form aluminum hydroxide carboxymethylcellulose sodium, unspecified form glycerin isopropyl myristate nonoxynol-30 polyacrylic acid (250000 mw) polysorbate 80 sodium polyacrylate (2500000 mw) sorbitan sesquioleate talc tartaric acid titanium dioxide water
Indications and Usage:
Uses temporarily relieves minor pain associated with: ⪠arthritis ⪠simple backache ⪠bursitis ⪠tendonitis ⪠muscle strains ⪠sprains ⪠bruises ⪠cramps
Warnings:
Warnings for external use only when using this product ⪠use only as directed. read and follow all directions and warnings on this label. ⪠avoid contact with 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 ⪠do not bandage tightly or apply local heat (such as heating pads) to the area of use ⪠a transient burning sensation may occur upon application but generally disappears in several days 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 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
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When Using:
When using this product ⪠use only as directed. read and follow all directions and warnings on this label. ⪠avoid contact with 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 ⪠do not bandage tightly or apply local heat (such as heating pads) to the area of use ⪠a transient burning sensation may occur upon application but generally disappears in several days
Dosage and Administration:
Directions adults 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 daily children 12 years or younger: ask a doctor
Stop Use:
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
Package Label Principal Display Panel:
Principal display panel - back & large areas menthol 5% icy hot ® original pain relief patch large patch feel it working instantly ⢠powerful targeted relief ⢠icy to dull, hot to relax ⢠comfortable fabric ⢠stays in place wear for up to 8 hours contains 5 patches in 1 resealable pouch 3-15/16â x 7-13/16â (10 cm x 20 cm) each chattem ® a sanofi company dist. by chattem, inc., a sanofi company p.o. box 2219 chattanooga, tn 37409-0219 usa ©2020 www.icyhot.com pouch label - back and large areas pouch label - back and large areas
Principal display panel - back & large areas â single patch menthol 5% icy hot ® original pain relief patch large patch feel it working instantly ⢠powerful targeted relief ⢠icy to dull, hot to relax ⢠comfortable fabric ⢠stays in place wear for up to 8 hours contains 1 patch 3-15/16â x 7-13/16â (10 cm x 20 cm) chattem ® a sanofi company dist. by chattem, inc., a sanofi company p.o. box 2219 chattanooga, tn 37409-0219 usa ©2020 www.icyhot.com pouch label - back and large areas â single patch pouch label - back and large areas â single patch