Will Cool Roll-on
Camphor (synthetic) And Menthol, Unspecified Form
Will Perform, Pbc
Human Otc Drug
NDC 82630-004Will Cool Roll-on also known as Camphor (synthetic) And Menthol, Unspecified Form is a human otc drug labeled by 'Will Perform, Pbc'. National Drug Code (NDC) number for Will Cool Roll-on is 82630-004. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Will Cool Roll-on drug includes Camphor (synthetic) - 3.3 g/88mL Menthol, Unspecified Form - 5 g/88mL . The currest status of Will Cool Roll-on drug is Active.
Drug Information:
| Drug NDC: | 82630-004 |
| 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: | Will Cool Roll-on |
| 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 (synthetic) And Menthol, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Will Perform, Pbc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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) - 3.3 g/88mL
MENTHOL, UNSPECIFIED FORM - 5 g/88mL
|
| 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 Aug, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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, 2024 |
| 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: | Will Perform, PBC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0382630000071
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 82630-004-01 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (82630-004-01) / 88 mL in 1 BOTTLE, WITH APPLICATOR | 01 Aug, 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:
Active ingredient purpose menthol 6% cooling pain relief camphor 4% cooling pain relief
Product Elements:
Will cool roll-on camphor (synthetic) and menthol, unspecified form camphor (synthetic) camphor (synthetic) menthol, unspecified form menthol, unspecified form alcohol aminomethylpropanol carbomer copolymer type b (allyl pentaerythritol crosslinked) glycerin panax notoginseng root polysorbate 20 propanediol salix alba bark sorbitan monooleate water
Indications and Usage:
Use temporarily relieves minor pain of sore muscles and joints associated with arthritis, backache, strains and sprains
Warnings:
Warnings for external use only flammable keep away from excessive heat or open flame do not use if you have had an allergic reaction to any of the ingredients in this product on puncture wounds for more than one week without consulting a doctor 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 do not bandage do not apply local heat (such as heating pads) or medicated patch to the area of use do not apply to wounds or damaged skin do not use at the same time as other topical analgesics stop use and ask a doctor if conditions worsen or irritation develops redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days if pregnant or breastfeeding, ask a healthcare professional before use keep out of reach of children and pets if swallowed, get medical help or contact a poison control center right away
Do Not Use:
Warnings for external use only flammable keep away from excessive heat or open flame do not use if you have had an allergic reaction to any of the ingredients in this product on puncture wounds for more than one week without consulting a doctor 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 do not bandage do not apply local heat (such as heating pads) or medicated patch to the area of use do not apply to wounds or damaged skin do not use at the same time as other topical analgesics stop use and ask a doctor if conditions worsen or irritation develops redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days if pregnant or breastfeeding, ask a healthcare professional before use keep out of reach of children and pets 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 avoid contact with eyes and mucous membranes do not bandage do not apply local heat (such as heating pads) or medicated patch to the area of use do not apply to wounds or damaged skin do not use at the same time as other topical analgesics
Dosage and Administration:
Directions adults and children over 12 years: apply to affected area not more than 4 times daily wash hands after use if product comes in contact with hands children 12 years or younger: ask a doctor
Stop Use:
Stop use and ask a doctor if conditions worsen or irritation develops redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Principal display panel - 88 ml bottle carton menthol & camphor cooling pain relief roll-on 3 fl oz (88 ml) principal display panel - 88 ml bottle carton