Biofreeze Overnight Relief
Menthol, Unspecified Form
Rb Health (us) Llc
Human Otc Drug
NDC 59316-005Biofreeze Overnight Relief also known as Menthol, Unspecified Form is a human otc drug labeled by 'Rb Health (us) Llc'. National Drug Code (NDC) number for Biofreeze Overnight Relief is 59316-005. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Biofreeze Overnight Relief drug includes Menthol, Unspecified Form - .3 g/6g . The currest status of Biofreeze Overnight Relief drug is Active.
Drug Information:
| Drug NDC: | 59316-005 |
| 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: | Biofreeze Overnight Relief |
| 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, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rb Health (us) Llc |
| 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 - .3 g/6g
|
| 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 Feb, 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, 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: | RB Health (US) LLC
|
| 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 |
|---|
| 59316-005-03 | 6 g in 1 PATCH (59316-005-03) | 01 Feb, 2022 | N/A | No |
| 59316-005-04 | 4 PATCH in 1 CARTON (59316-005-04) / 6 g in 1 PATCH (59316-005-03) | 01 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 topical analgesic
Product Elements:
Biofreeze overnight relief menthol, unspecified form menthol, unspecified form menthol, unspecified form benzalkonium chloride carboxymethylcellulose sodium, unspecified dihydroxyaluminum aminoacetate edetate disodium glycerin kaolin lauralkonium chloride lavender oil mineral oil petrolatum polysorbate 80 propylene glycol povidone, unspecified tartaric acid titanium dioxide water polyacrylic acid (450000 mw) sodium polyacrylate (2500000 mw)
Indications and Usage:
Uses temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
Warnings:
Warnings for external use only. when using this product use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptons persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present 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 avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device
Dosage and Administration:
Directions adults and children 12 years of age and older: clean and dry affected area pop apart and partially peel back protective film and apply exposed patch to site of pain. carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. use on affected area not more than 3 to 4 times daily. children under 12 years of age: consult a physician wash hands after use with cool water
Stop Use:
Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptons persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present
Package Label Principal Display Panel:
Principal display panel - 4 patch pouch carton clinically recommended ndc 59316-005-04 biofreeze ® cool the pain overnight relief patches menthol-topical analgesic overnight pain relief patch scented with lavender essential oil designed to stay on through the night optimized for comfort and flexibility 4 patches 5.125 in x 2.6 in (13 cm x 6.6 cm) each principal display panel - 4 patch pouch carton
Further Questions:
Questions or comments? 1-800-246-3733