Bioflexor 04
Menthol
Health Care Laboratories Inc.
Human Otc Drug
NDC 62391-100Bioflexor 04 also known as Menthol is a human otc drug labeled by 'Health Care Laboratories Inc.'. National Drug Code (NDC) number for Bioflexor 04 is 62391-100. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Bioflexor 04 drug includes Menthol - 3 g/100g . The currest status of Bioflexor 04 drug is Active.
Drug Information:
| Drug NDC: | 62391-100 |
| 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: | Bioflexor 04 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Bioflexor |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 04 |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Health Care Laboratories Inc. |
| 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: | MENTHOL - 3 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: | 01 Mar, 1998 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | Health Care Laboratories Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 259150
1304408
|
| 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 |
|---|
| 62391-100-02 | 67.5 g in 1 JAR (62391-100-02) | 01 Mar, 1998 | N/A | No |
| 62391-100-04 | 135 g in 1 JAR (62391-100-04) | 01 Mar, 1998 | N/A | No |
| 62391-100-30 | 960 g in 1 JAR (62391-100-30) | 01 Mar, 1998 | 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:
Bioflexor 04 menthol menthol menthol butylparaben camphor (synthetic) carbomer homopolymer, unspecified type eucalyptus oil phenoxyethanol sodium hydroxide ilex paraguariensis leaf edetate disodium ethylparaben methylparaben propylparaben yucca schidigera stem aloe vera leaf isobutylparaben polysorbate 20 water potassium sorbate
Indications and Usage:
Uses temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
Warnings:
Warnings section warnings for external use only. do not use: ⢠on wounds or damaged skin ⢠with a heating pad ⢠on a child under 12 years of age with arthritis-like conditions ask a doctor before use if you have redness over the affected area. when using this product: ⢠avoid contact with the eyes or mucous membranes ⢠do not bandage tightly stop use and ask a doctor if: ⢠condition worsens or symptoms persist for more than 7 days ⢠symptoms clear up and occur again within a few days ⢠excessive skin irritation occurs keep out of reach of children. if swallowed, get medical help or contact the poison control center right away.
Dosage and Administration:
Dosage and administration directions adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 12 years of age: consult a doctor
Description:
Product description description: bioflexor® gel is an otc topical analgesic preparation which delivers deep penetrating, effective pain relief. bioflexor® is a unique product from several viewpoints. in developing bioflexor®, our main focus was to formulate a potent topical analgesic agent that would minimize the need for oral narcotic analgesics. the result is an exceptional product that truly helps those individuals suffering from the pain associated with the spectrum of medical conditions from arthritis to muscle aches and pain, simple back aches, strains, bruises, and sprains.. menthol is the only listed active ingredient on the bioflexor® label. the other all natural components work synergistically to produce the pain relieving activity. another unique aspect of bioflexor® relates to the immediate and long-lasting pain relief without the side effects of lingering scent (methyl salicylate rubs, ie. ben gay), burning sensation (capsaicin ie. zostrix, theragesic, icy-hot), greasy residue (ie. aspercreme, ben-gay), and dry skin (alcohol formulations, ie. biofreeze). the bioflexor® formulation contains no alcohol, capsaicin, or methyl salicylate.
Mechanism of Action:
Mechanism of action mechanism of action: the initial pain relief mechanism produced by the absorption of bioflexor® generates a topical cooling effect. this is a result of vasoconstriction of peripheral vessels in the affected areas, yielding a decreased blood flow. this action causes a decrease in temperature of the skin and subcutaneous tissues. as penetration continues, an interruption of sympathetic nerve conduction occurs, producing a warm vasodilation. this in turn increases the blood flow to muscle tissues and to the surface of the skin, promoting the healing process and rendering analgesic properties
Package Label Principal Display Panel:
Principal display panel bioflexor 4.5oz