Icy Hot Back And Large Areas

Menthol


Chattem, Inc.
Human Otc Drug
NDC 41167-0843
Icy Hot Back And Large Areas also known as Menthol is a human otc drug labeled by 'Chattem, Inc.'. National Drug Code (NDC) number for Icy Hot Back And Large Areas is 41167-0843. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Icy Hot Back And Large Areas drug includes Menthol - 428.5 mg/1 . The currest status of Icy Hot Back And Large Areas drug is Active.

Drug Information:

Drug NDC: 41167-0843
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 Back And Large Areas
Also known as the trade name. It is the name of the product chosen by the labeler.
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: Chattem, Inc.
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 - 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: 01 Mar, 2003
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 05 May, 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:Chattem, Inc.
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
41167-0843-11 POUCH in 1 CARTON (41167-0843-1) / 5 PATCH in 1 POUCH01 Mar, 2003N/ANo
41167-0843-21 POUCH in 1 CARTON (41167-0843-2) / 6 PATCH in 1 POUCH01 Mar, 2003N/ANo
41167-0843-73 POUCH in 1 CARTON (41167-0843-7) / 5 PATCH in 1 POUCH01 Mar, 2003N/ANo
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

Purpose topical analgesic

Purpose topical analgesic

Product Elements:

Icy hot arm neck leg and small areas menthol menthol menthol acrylic acid polyacrylic acid (250000 mw) sodium polyacrylate (2500000 mw) aluminum hydroxide carboxymethylcellulose sodium glycerin isopropyl myristate methyl acrylate ethylhexyl acetate nonoxynol-30 polysorbate 80 sorbitan sesquioleate talc tartaric acid titanium dioxide water icy hot back and large areas menthol menthol menthol acrylic acid sodium polyacrylate (2500000 mw) polyacrylic acid (250000 mw) aluminum hydroxide carboxymethylcellulose sodium glycerin isopropyl myristate methyl acrylate ethylhexyl acetate nonoxynol-30 polysorbate 80 sorbitan sesquioleate talc tartaric acid titanium dioxide water icy hot xl back and large areas menthol menthol menthol acrylic acid aluminum hydroxide carboxymethylcellulose sodium ethylhexyl acetate glycerin isopropyl myristate methyl acrylate nonoxynol-30 polysorbate 80 sorbitan sesquioleate talc tartaric acid titanium dioxide water polyacrylic acid (250000 mw) sodium polyacrylate (2500000 mw) icy hot back and large areas menthol menthol menthol acrylic acid aluminum hydroxide carboxymethylcellulose sodium ethylhexyl acetate glycerin isopropyl myristate methyl acrylate nonoxynol-30 polysorbate 80 sorbitan sesquioleate talc tartaric acid titanium dioxide water sodium polyacrylate (2500000 mw) polyacrylic acid (250000 mw) icy hot back and large areas menthol menthol menthol acrylic acid aluminum hydroxide carboxymethylcellulose sodium ethylhexyl acetate glycerin isopropyl myristate methyl acrylate nonoxynol-30 polysorbate 80 sorbitan sesquioleate talc tartaric acid titanium dioxide water polyacrylic acid (250000 mw) sodium polyacrylate (2500000 mw)

Indications and Usage:

Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains sprains bruises cramps

Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains sprains bruises cramps

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 carton. 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 skin, 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 control center right away.

Warnings for external use only when using this product use only as directed. read and follow all directions and warnings on this carton. 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 skin, 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 control center right away.

Warnings for external use only when using this product use only as directed. read and follow all directions and warnings on this carton. 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 skin, 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 control center right away.

When Using:

When using this product use only as directed. read and follow all directions and warnings on this carton. 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 skin, 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

When using this product use only as directed. read and follow all directions and warnings on this carton. 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 skin, 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

When using this product use only as directed. read and follow all directions and warnings on this carton. 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 skin, 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 apply one patch to affected area wear one icy hot patch up to 8 hours repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor

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 apply one patch to affected area wear one icy hot patch up to 8 hours repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor

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 apply one patch to affected area wear one icy hot patch 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

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

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 icy hot ® original pain relief patch menthol 5% icy to dull, hot to relax wear for up to 8 hours small patch 3-1/8” x 4-5/8” (8 cm x 12 cm) each arm. neck & leg patch contains 5 patches in 1 resealable pouch icy hot® original pain relief patch menthol 5% icy to dull, hot to relax wear for up to 8 hours small patch 3-1/8” x 4-5/8” (8 cm x 12 cm) each arm. neck & leg patch contains 5 patches in 1 resealable pouch

Principal display panel icy hot ® original pain relief patch menthol 5% icy to dull, hot to relax wear for up to 8 hours large patch 3-15/16 ” x 7-13/16 ” ( 10 cm x 20 cm) each contains 5 patches i n 1 resealable pouch principal display panel icy hot® original pain relief patch menthol 5% icy to dull, hot to relax wear for up to 8 hours large patch 3-15/16” x 7-13/16” (10 cm x 20 cm) each contains 5 patches in 1 resealable pouch

Principal display panel icy hot ® original pain relief patch menthol 5% icy to dull, hot to relax wear for up to 8 hours xl patch 5-1 / 2 ” x 9 -3/ 4 ” (1 4 cm x 2 5 cm) each contains 3 patches in 1 resealable pouch principal display panel icy hot® original pain relief patch menthol 5% icy to dull, hot to relax wear for up to 8 hours xl patch 5-1/2” x 9-3/4” (14 cm x 25 cm) each contains 3 patches in 1 resealable pouch

Principal display panel icy hot ® original pain relief patch principal display panel icy hot® original pain relief patch

Principal display panel icy hot ® original pain relief patch menthol 5% principal display panel icy hot® original pain relief patch menthol 5%


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.