Cvs Health Cold And Hot Roll-on Menthol
Menthol, Unspecified Form
Natural Essentials, Inc.
Human Otc Drug
NDC 66902-241Cvs Health Cold And Hot Roll-on Menthol also known as Menthol, Unspecified Form is a human otc drug labeled by 'Natural Essentials, Inc.'. National Drug Code (NDC) number for Cvs Health Cold And Hot Roll-on Menthol is 66902-241. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cvs Health Cold And Hot Roll-on Menthol drug includes Menthol, Unspecified Form - 160 mg/mL . The currest status of Cvs Health Cold And Hot Roll-on Menthol drug is Active.
Drug Information:
| Drug NDC: | 66902-241 |
| 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: | Cvs Health Cold And Hot Roll-on Menthol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Cvs Health Cold And Hot Roll-on |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Menthol |
| 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, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natural Essentials, 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: | MENTHOL, UNSPECIFIED FORM - 160 mg/mL
|
| 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: | 17 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | NATURAL ESSENTIALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 866084
|
| 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 |
|---|
| 66902-241-25 | 1 CONTAINER in 1 BOX (66902-241-25) / 73 mL in 1 CONTAINER | 17 Jan, 2018 | 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:
Cvs health cold and hot roll-on menthol menthol, unspecified form menthol, unspecified form menthol, unspecified form carbomer copolymer type a (allyl pentaerythritol crosslinked) aminomethylpropanol capsaicin water glycerin isopropyl myristate propylene glycol alcohol
Indications and Usage:
Uses: temporarily relieves minor pain associated with: arhtritis simple backache 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. rare cases of serious burns have been reported with products of this type do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use avoid contact with eyes or mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight 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. flammable keep away from fire or flame.
Read more... 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 label. rare cases of serious burns have been reported with products of this type do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use avoid contact with eyes or mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight avoid applying into skin folds.
Dosage and Administration:
Directions: adults and children over 12 years: apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily if medicine comes in contact with hands, wash with soap and water 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 - cold & hot roll-on menthol 16% box label cvs health⢠compare to the active ingredient in maximum strength icyhot ® pain relieving liquid maximum strength cold & hot roll-on menthol 16% pain-relieving liquid long-lasting formula no-touch applicator dries quickly actual product size on side panel 2.5 fl oz (73 ml) principal display panel - cold & hot roll-on menthol 16% box label
Principal display panel - cold & hot roll-on menthol 16% container label cvs health⢠maximum strength cold & hot roll-on menthol 16% pain-relieving liquid long-lasting formula no-touch applicator dries quickly 2.5 fl oz (73 ml) principal display panel - cold & hot roll-on menthol 16% container label