Icy Hot Pro No-mess
Camphor, Menthol
Chattem, Inc.
Human Otc Drug
NDC 41167-0079Icy Hot Pro No-mess also known as Camphor, Menthol is a human otc drug labeled by 'Chattem, Inc.'. National Drug Code (NDC) number for Icy Hot Pro No-mess is 41167-0079. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Icy Hot Pro No-mess drug includes Camphor (synthetic) - 11 g/100g Menthol - 16 g/100g . The currest status of Icy Hot Pro No-mess drug is Active.
Drug Information:
| Drug NDC: | 41167-0079 |
| 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 Pro No-mess |
| 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: | Camphor, 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: | Liquid |
| 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: | CAMPHOR (SYNTHETIC) - 11 g/100g MENTHOL - 16 g/100g
|
| 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: | 21 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | 1373219
|
| 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: | 5TJD82A1ET 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 |
|---|
| 41167-0079-6 | 85 g in 1 BOTTLE (41167-0079-6) | 21 Feb, 2022 | 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 camphor 11%, menthol 16%...........................................................................................................topical analgesic
Product Elements:
Icy hot pro no-mess camphor, menthol camphor (synthetic) camphor (synthetic) menthol menthol 4-tert-butylcyclohexanol alcohol allantoin aloe vera leaf cetyl alcohol grapefruit oil farnesol glyceryl monostearate peppermint oil spearmint oil pentylene glycol propanediol steareth-21 stearic acid trolamine water carbomer interpolymer type a (55000 cps) menthyl lactate, (-)- diisopropyl adipate diethylene glycol monoethyl ether glyceryl dilaurate polysorbate 80 peg-150 stearate soy sterol phenoxyethanol methylparaben glycerin edetate disodium anhydrous xanthan gum
Indications and Usage:
Uses temporarily relieves minor aches and pains of muscles and joints associated with: â arthritis â simple backache â strains â sprains â bruises
Warnings:
Warnings for external use only do not use â on wounds or on irritated or damaged skin â with a heating pad when using this product â use only as directed â do not bandage tightly â avoid contact with eyes and mucous membranes â do not expose the area to local heat or direct sunlight â rare cases of serious burns have been reported with products of this type â a transient burning sensation may occur upon application but generally disappears in several days â avoid applying into skin folds stop use and ask a doctor if â condition worsens or symptoms persist for more than 7 days â symptoms clear up and occur again within a few days â redness is present or excessive skin irritation occurs â you experience severe burning 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 poiso
Read more...n control center right away.
Do Not Use:
Warnings for external use only do not use â on wounds or on irritated or damaged skin â with a heating pad when using this product â use only as directed â do not bandage tightly â avoid contact with eyes and mucous membranes â do not expose the area to local heat or direct sunlight â rare cases of serious burns have been reported with products of this type â a transient burning sensation may occur upon application but generally disappears in several days â avoid applying into skin folds stop use and ask a doctor if â condition worsens or symptoms persist for more than 7 days â symptoms clear up and occur again within a few days â redness is present or excessive skin irritation occurs â you experience severe burning 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 â use only as directed â do not bandage tightly â avoid contact with eyes and mucous membranes â do not expose the area to local heat or direct sunlight â rare cases of serious burns have been reported with products of this type â a transient burning sensation may occur upon application but generally disappears in several days â avoid applying into skin folds
Dosage and Administration:
Directions adults and children 12 years of age and older: â apply to affected area not more than 3 to 4 times daily â remove protective cap and lift white applicator at arrows â squeeze tube gently while holding upright to dispense a small amount of product â press down to close applicator prior to application â massage product into skin using applicator until thoroughly absorbed â if needed, clean applicator by rinsing with water or wipe clean with a cloth. â wash hands thoroughly with soap and water if product comes in contact with hands children under 12 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if â condition worsens or symptoms persist for more than 7 days â symptoms clear up and occur again within a few days â redness is present or excessive skin irritation occurs â you experience severe burning pain, swelling, or blistering where the product was applied
Package Label Principal Display Panel:
Principal display panel icy hot pro no mess pain reliever net wt 3 oz (85 g) principal display panel icyhot pro no mess pain reliever net wt 3 oz (85 g)